Javelin Parp Medley: Avelumab Plus Talazoparib In Locally... | NCT03330405 | Trialant
NCT03330405
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Oct 13, 2023Actual
Enrollment
223Actual
Phase
Phase 1Phase 2
Conditions
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Interventions
Avelumab Phase 1b
Talazoparib Phase 1b
Avelumab Phase 2
Talazoparib Phase 2
Countries
United States
Australia
Belgium
Canada
Denmark
Hungary
Russia
South Korea
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03330405
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B9991025
Secondary IDs
ID
Type
Description
Link
2017-001509-33
EudraCT Number
JAVELIN PARP MEDLEY
Other Identifier
Alias Study Number
Brief Title
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Official Title
A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLY(ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522).
Expanded Access Info
No
Start Date
Oct 19, 2017Actual
Primary Completion Date
Feb 22, 2022Actual
Completion Date
Jan 4, 2023Actual
First Submitted Date
Oct 16, 2017
First Submission Date that Met QC Criteria
Oct 30, 2017
First Posted Date
Nov 6, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 10, 2023
Results First Submitted that Met QC Criteria
May 17, 2023
Results First Posted Date
Jun 12, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 11, 2023
Last Update Posted Date
Oct 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).
Detailed Description
Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 (PD 1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.
Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).
Conditions Module
Conditions
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Keywords
NSCLC, TNBC, hormone receptor positive (HR+) breast cancer, recurrent epithelial ovarian cancer, UC, and castration resistant prostate cancer (CRPC).
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
223Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Level 0 Phase 1b
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 1b
Drug: Talazoparib Phase 1b
Dose Level -1 Phase 1b
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 1b
Drug: Talazoparib Phase 1b
Dose Level -2 Phase 1b
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 1b
Drug: Talazoparib Phase 1b
A1. NSCLC Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
A2. NSCLC PD-L1 Resistant DDR+ Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
B1. TNBC Phase 2
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Avelumab Phase 1b
Drug
Avelumab
Dose Level -1 Phase 1b
Dose Level -2 Phase 1b
Dose Level 0 Phase 1b
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs=occurrence of any of the following AEs attributable to any study treatment in Cycle 1:Hematologic: grade(G)4 neutropenia lasting >5 days (absolute neutrophil count [ANC]< 0.5*10^9/L); febrile neutropenia; neutropenic infection (ANC<1.0*10^9/L, and G>3 infection); G>=3 thrombocytopenia (platelet count [PC] <50.0*10^9/L) with bleeding; G4 thrombocytopenia (PC<25.0*10^9/L); G4 anemia (life-threatening; urgent intervention indicated). Non-hematologic: G>=3 toxicities unless predefined in the protocol; potential Hy's law cases. Non-adherence to treatment schedule: failure to deliver at least 75% of the planned doses of talazoparib during the first cycle of treatment due to treatment-related toxicities; G3 non-hematologic toxicity that delayed administration of either study drug for more than 2 weeks. Dose reductions: any adverse event (AE) that resulted in a dose reduction of talazoparib.
Cycle 1; 28 days
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
This outcome measure (OM) is reported for participants with solid tumors except mCRPC; for those participants, OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version(v) 1.1 by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 4.3 years approximately)
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3) by Investigator Assessment
This OM is reported for participants with mCRPC; for those participants, OR was defined as the proportion of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 and with no evidence of confirmed bone disease progression per PCWG3 criteria by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-PD.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
Minimum age in Japan is 20 years.
ECOG performance status 0 or 1.
Resolved acute effects of prior therapy
Adequate bone marrow, renal, and liver function.
Negative serum pregnancy test at screening.
Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
Signed and dated informed consent.
Exclusion Criteria:
Prior treatment with a PARP inhibitor.
Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed
Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
Major surgery within 4 weeks prior to study enrollment.
Current use of immunosuppressive medication at the time of study enrollment.
Known prior or suspected hypersensitivity to investigational products.
Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
Prior organ transplantation including allogenic stem-cell transplantation.
Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
Diagnosis of Myelodysplastic Syndrome.
Patients with known brain metastases requiring steroids.
Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
Persisting toxicity related to prior therapy >Grade 1
Known HIV or AIDs-related illness.
Positive HBV or HCV test indicating acute or chronic infection.
Active infection requiring systemic therapy.
Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor.
Other acute or chronic medical or psychiatric conditions.
Yap TA, Bardia A, Dvorkin M, Galsky MD, Beck JT, Wise DR, Karyakin O, Rubovszky G, Kislov N, Rohrberg K, Joy AA, Telli ML, Schram AM, Conte U, Chappey C, Stewart R, Stypinski D, Michelon E, Cesari R, Konstantinopoulos PA. Avelumab Plus Talazoparib in Patients With Advanced Solid Tumors: The JAVELIN PARP Medley Nonrandomized Controlled Trial. JAMA Oncol. 2023 Jan 1;9(1):40-50. doi: 10.1001/jamaoncol.2022.5228.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Phase 1b: 12 participants were enrolled and assigned to study treatment. Phase 2: 211 participants were enrolled and assigned to study treatment.
Recruitment Details
The study was conducted in 2 phases: Phase 1b (talazoparib dose level cohorts) and Phase 2 (expansion phase). The Phase 1b study design started at the highest dose of talazoparib (1 mg QD), to be de-escalated to 0.75 and 0.5 mg QD. With DLT rate <33% among 12 DLT-evaluable patients treated at 1 mg, Phase 2 started. The 2 cohorts at lower dose did not enroll any participants and are not displayed in the results. Only the Phase 1b cohort "Avelumab 800 mg Q2W + Talazoparib 1 mg QD" is displayed.
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally once daily (QD) in combination with avelumab 800 mg intravenously (IV) every 2 weeks (Q2W) for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 20, 2018
Feb 8, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
B2. HR+BC DDR Defect +Assay Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
C1. Ovarian CA Recurrent Plat-Sensitive Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
D.Urothelial CA Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
E1. CRPC Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
E2. CRPC DDR Defect +Assay Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
F: Advanced Solid Tumors with BRCA or ATM defect Phase 2
Experimental
Drug: Avelumab
Drug: Talazoparib
Drug: Avelumab Phase 2
Drug: Talazoparib Phase 2
MSB0010718C
Talazoparib Phase 1b
Drug
Talazoparib
Dose Level -1 Phase 1b
Dose Level -2 Phase 1b
Dose Level 0 Phase 1b
MDV3800, BMN 673
Avelumab Phase 2
Drug
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
A1. NSCLC Phase 2
A2. NSCLC PD-L1 Resistant DDR+ Phase 2
B1. TNBC Phase 2
B2. HR+BC DDR Defect +Assay Phase 2
C1. Ovarian CA Recurrent Plat-Sensitive Phase 2
C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2
D.Urothelial CA Phase 2
E1. CRPC Phase 2
E2. CRPC DDR Defect +Assay Phase 2
F: Advanced Solid Tumors with BRCA or ATM defect Phase 2
MSB0010718C
Talazoparib Phase 2
Drug
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
A1. NSCLC Phase 2
A2. NSCLC PD-L1 Resistant DDR+ Phase 2
B1. TNBC Phase 2
B2. HR+BC DDR Defect +Assay Phase 2
C1. Ovarian CA Recurrent Plat-Sensitive Phase 2
C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2
D.Urothelial CA Phase 2
E1. CRPC Phase 2
E2. CRPC DDR Defect +Assay Phase 2
F: Advanced Solid Tumors with BRCA or ATM defect Phase 2
MDV3800, BMN 673
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 4.3 years approximately)
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With Grade >=3 TEAEs
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Grade 3 or higher TEAEs were reported.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With Serious TEAEs
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With TEAEs Leading to Discontinuation of Either Study Drug
Either study drug = avelumab only or talazoparib only. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With TEAEs Leading to Discontinuation of All Study Drugs
All study drugs = all study drugs in the combination. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With TEAEs Leading to Death
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Trough Concentrations (Ctrough)/Predose and Maximum Concentrations (Cmax) of Serum Avelumab Concentrations (μg/mL) by Visit (Excluding Site 1055)
Pharmacokinetics (PK) data analyses included descriptive summary statistics of the pre-dose/Ctrough concentrations for both investigational products and post-dose (for talazoparib) or Cmax concentrations (for avelumab) for each cycle.
Predose/0 Hour (H) and 1 H on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2-4, and additionally on Day 1 of Cycles 6, 9, 12, 18, and 24.
Predose and Postdose Plasma Talazoparib Concentrations (pg/mL) by Visit (Excluding Site 1055)
Pharmacokinetics (PK) data analyses included descriptive summary statistics of the pre-dose/Ctrough concentrations for both investigational products and post-dose (for talazoparib) or Cmax concentrations (for avelumab) for each cycle. Cmax=maximum concentration. Ctrough=trough concentration. Participants with moderate renal impairment were started at a lower, 0.75 mg QD, dose to compensate for decreased talazoparib clearance.
Pre-dose and post-dose (at the end of the avelumab infusion) on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2-4.
Number of Participants With at Least 1 Valid Anti-drug Antibody (ADA) Result at: Any Time Point (N0), Baseline (N1), Baseline and Post-Baseline (N2), and Post-Baseline and Without Positive Baseline ADA Result (N3)
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline was defined as the last assessment prior to the date/time of the first dose of avelumab. N0, N1, N2, and N3=Number of participants with at least 1 valid ADA result at any time point, baseline (pre-dose on Day 1), baseline and post-baseline, and post-baseline, respectively.
Pre-dose (within 2 hours of talazoparib dose) on Day 1 and Day 15 of Cycle 1, on Day 1 of Cycle 2-4 and then on Day 1 of Cycles 6, 9, 12, 18, 24, and at the end of treatment (EOT)
Number of Participants by ADA Categories
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline was defined as the last assessment prior to the date/time of the first dose of avelumab. N0, N1, N2, and N3=Number of participants with at least 1 valid ADA Result at any time point, baseline (pre-dose on Day 1), baseline and post-baseline, and post-baseline, respectively. n=number of participants in each category.
Pre-dose (within 2 hours of talazoparib dose) on Day 1 and Day 15 of Cycles 1, on Day 1 of Cycle 2-4 and then on Day 1 of Cycles 6, 9, 12, 18, 24, and at the end of treatment (EOT)
Phase 1b: Percentage of Participants With Confirmed OR as Per RECIST v1.1 and PCWG3 by Investigator Assessment
This OM is reported for participants in Phase 1b; OR was defined as the proportion of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 and with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-PD.
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Phase 1b: Time to Response (TTR) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, TTR was defined for participants with confirmed OR (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC, TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a best overall response (BOR) of CR or PR as assessed by Investigator using RECIST v1.1.
From the first dose of study treatment to the first documentation of objective tumor response/the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression (<=5.2 years approximately)
Phase 2: TTR in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, TTR was defined for participants with confirmed OR (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC, TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a best overall response (BOR) of CR or PR as assessed by Investigator using RECIST v1.1.
From the first dose of study treatment to the first documentation of objective tumor response/the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression (<= 5.2 years approximately)
Phase 2: Duration of Response (DR) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, DR was defined for participants with confirmed OR (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.
From the first objective tumor response/soft tissue response to the first objective tumor progression/subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first (<=5.2 years approximately)
Phase 1b: Progression-Free Survival (PFS) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC, PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using RECIST v1.1, in bone as assessed by Investigator using PCWG3, or death, whichever occurred first
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Phase 2: PFS in Participants With Confirmed CR or PR (RECIST v1.1)
This OM is reported for participants with solid tumors except mCRPC; for those participants, PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first.
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Phase 2: PFS in Participants With Confirmed CR or PR (RECIST v1.1 and PCWG3)
This OM was reported for participants with mCRPC; for these participants, PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using RECIST v1.1, in bone as assessed by Investigator using PCWG3, or death, whichever occurred first.
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Phase 2: Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC
Time to PSA progression for participants with mCRPC was defined as the time from the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later.
From the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented (maximum up to 5.2 years approximately)
Phase 1b: Overall Survival
Overall survival (OS) was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact.
From the first dose of study treatment to the date of death (maximum up to 5.2 years approximately)
Phase 2: Overall Survival
OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact.
From the first dose of study treatment to the date of death (maximum up to 5.2 years approximately)
Phase 2: Percentage of Participants With PSA Response
PSA response was defined as the proportion of participants with confirmed PSA decline >=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must be confirmed by a second consecutive value at least 3 weeks later.
From baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50% (maximum up to 5.2 years approximately)
Phase 1b: Percentage of Participants With CA-125 Response
Cancer Antigen 125 (CA-125) response is defined as at least a 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.
From baseline to at least a 50% reduction in CA-125 level (maximum up to 5.2 years approximately)
Phase 2: Percentage of Participants With CA-125 Response
CA-125 response is defined as at least a 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.
From baseline to at least a 50% reduction in CA-125 level (maximum up to 5.2 years approximately)
Number of Participants With Different Programmed Death-Ligand 1 (PD-L1) Status at Baseline
PD-L1 expression on tumor and infiltrating immune cells were measured by immunohistochemistry (IHC). PD-L1 expression level corresponds to the percentage of positive cells. The PD-L1 Positive category does not apply to cohorts A1 and A2. The PD-L1 High/Low categories only apply to cohorts A1 and A2. Participants were considered positive if their baseline tumor tissue sample demonstrated cell surface PD-L1 expression: 1) for Cohorts E1, E2, and F: >=1% tumor cells (TC) or >= 5% immune cells (IC); 2) for Cohort D: TC/IC>=25%; 3) for Cohorts B1, B2, C1, C2: IC>=5%; otherwise were considered negative. Categories based on PD-L1 expression level ≥50% and <50% were defined as High and Low, respectively.
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
Number of Participants With Different Tumor Mutational Burden (TMB) at Baseline
TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. High: TMB score >=20 muts/mb (number of mutations per megabase of DNA); Medium: TMB score >=10 muts/mb and <20 muts/mb; Low: TMB score <10 muts/mb.
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
Number of Participants With Different DNA Damage Repair (DDR) Status at Baseline
DDR defect positive was determined by presence of one or more pathogenic or likely pathogenic mutations in tissue, DNA and/or blood samples.
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
Fayetteville
Arkansas
72703
United States
Highlands Oncology Group
Rogers
Arkansas
72758
United States
Highlands Oncology
Rogers
Arkansas
72758
United States
Highlands Oncology Group
Springdale
Arkansas
72762
United States
Highlands Oncology
Springdale
Arkansas
72762
United States
Tower Hematology Oncology Medical Group
Beverly Hills
California
90211
United States
Keck Hospital of USC
Los Angeles
California
90033
United States
LAC+USC Medical Center
Los Angeles
California
90033
United States
USC/Norris Comprehensive Cancer Center/Investigational Drug Services
Los Angeles
California
90033
United States
USC/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
Hoag Memorial Hospital Presbyterian
Newport Beach
California
92663
United States
Freidenrich Center for Translational Research (CTRU)
Palo Alto
California
94304
United States
Stanford Cancer Institute
Stanford
California
94305
United States
Stanford Hospital and Clinics
Stanford
California
94305
United States
Stanford Women's Cancer Center
Stanford
California
94305
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Massachusetts General Hospital (MGH)
Boston
Massachusetts
02114
United States
Massachusetts General Hospital Attn: Lalit Joshi
Boston
Massachusetts
02114
United States
Massachusetts General Hospital Attn: Svetlana Rashkova
Boston
Massachusetts
02114
United States
Brigham & Women's Hospital
Boston
Massachusetts
02115
United States
Dana Farber Cancer Institute, Attn: Vasilika Koci, PharmD
Boston
Massachusetts
02215
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University Of Minesota Health: Clinics And Surgery Center
Minneapolis
Minnesota
55455
United States
University of Minesota Medical Center, Fairview IDS Pharmacy
Minneapolis
Minnesota
55455
United States
University of Minnesota Medical Center, Fairview
Minneapolis
Minnesota
55455
United States
Roswell Park Cancer Center Institute
Buffalo
New York
14263
United States
NYU Investigational Pharmacy
New York
New York
10016
United States
NYU Langone Medical Center
New York
New York
10016
United States
NYU Langone Radiology
New York
New York
10016
United States
NYU Laura and Isaac Perlmutter Cancer Center
New York
New York
10016
United States
NYU Langone Radiology - Ambulatory Care Center
New York
New York
10017
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10029
United States
Mount Sinai Hospital- Pharmacy department
New York
New York
10029
United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland
Ohio
44106
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Macquarie University
North Ryde
New South Wales
2109
Australia
Northern Cancer Institute
St Leonards
New South Wales
2065
Australia
Northern Cancer Institute
Sydney
New South Wales
2065
Australia
Mater Misericordiae Ltd
Brisbane
Queensland
4101
Australia
Fiona Stanley Hospital
Murdoch
Western Australia
6150
Australia
Institut Jules Bordet
Brussels
1000
Belgium
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi
6000
Belgium
Cross Cancer Institute
Edmonton
Alberta
T6G 1Z2
Canada
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 2M9
Canada
Phase 1 Unit, Department of Oncology, Section 5073.
Copenhagen
2100
Denmark
Herlev og Gentofte Hospital
Herlev
2730
Denmark
The Experimental Cancer Therapy Unit
Herlev
2730
Denmark
Orszagos Onkologiai Intezet
Budapest
H-1122
Hungary
CRU Hungary Kft.
Miskolc
3529
Hungary
Pecsi Tudomanyegyetem
Pécs
H-7624
Hungary
Medical Radiological Research Center n.a. A.F. Tsyba -
Obninsk
Kaluga Oblast
249036
Russia
Medical Radiological Research Center n.a. A.F. Tsyba
Obninsk
Kaluga Oblast
249036
Russia
GBUZ
Chelyabinsk
454087
Russia
FSBI "National Medical Research Centre of Oncology n.a.
Moscow
115478
Russia
Budget Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk
644013
Russia
State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital"
Yaroslavl
150054
Russia
Gachon University Gil Medical Center
Incheon
21565
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Asan Medical Center
Seoul
05505
South Korea
University College London Hospitals NHS Foundation Trust
London
Other
W1T 7HA
United Kingdom
University Hospitals of Leicester NHS Trust
Leicester
LE1 5WW
United Kingdom
Freeman Hospital, The Sir Bobby Robson Cancer Trials
Newcastle upon Tyne
NE7 7DN
United Kingdom
FG001
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG002
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG003
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG004
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG005
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG006
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG007
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG008
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG009
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
FG010
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally once daily (QD) in combination with avelumab 800 mg intravenously (IV) every 2 weeks (Q2W) for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG001
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG002
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG003
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG004
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG005
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG006
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG007
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG008
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG009
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG010
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00142
BG0025
BG00322
BG00423
BG00520
BG00611
BG00740
BG00821
BG00918
BG0109
BG011223
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Mean
Title
Measurements
BG00062.67± 9.49
BG00167.00± 9.37
BG00259.60± 7.40
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<65 years
Title
Measurements
BG0006
BG00115
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0003
BG0011
BG002
Geographic Region
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
North America
BG00012
BG0019
BG002
ECOG Performance Status
ECOG=Eastern Cooperative Oncology Group. Score 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work or office work.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0004
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs=occurrence of any of the following AEs attributable to any study treatment in Cycle 1:Hematologic: grade(G)4 neutropenia lasting >5 days (absolute neutrophil count [ANC]< 0.5*10^9/L); febrile neutropenia; neutropenic infection (ANC<1.0*10^9/L, and G>3 infection); G>=3 thrombocytopenia (platelet count [PC] <50.0*10^9/L) with bleeding; G4 thrombocytopenia (PC<25.0*10^9/L); G4 anemia (life-threatening; urgent intervention indicated). Non-hematologic: G>=3 toxicities unless predefined in the protocol; potential Hy's law cases. Non-adherence to treatment schedule: failure to deliver at least 75% of the planned doses of talazoparib during the first cycle of treatment due to treatment-related toxicities; G3 non-hematologic toxicity that delayed administration of either study drug for more than 2 weeks. Dose reductions: any adverse event (AE) that resulted in a dose reduction of talazoparib.
The DLT analysis set was a subset of the safety analysis set and included all enrolled participants in the Phase 1b portion who were eligible for the study, received at least 1 dose of the combination treatment, and either experienced DLT during the first cycle (28 days) of treatment, or completed the DLT observation period for the first cycle of treatment.
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG0003
Primary
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
This outcome measure (OM) is reported for participants with solid tumors except mCRPC; for those participants, OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version(v) 1.1 by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was not planned to be collected and analyzed for Phase 1b arm. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 4.3 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Primary
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3) by Investigator Assessment
This OM is reported for participants with mCRPC; for those participants, OR was defined as the proportion of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 and with no evidence of confirmed bone disease progression per PCWG3 criteria by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-PD.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was not planned to be collected and analyzed for Phase 1b arm. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 4.3 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Secondary
Number of Participants With Grade >=3 TEAEs
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v 4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Grade 3 or higher TEAEs were reported.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Secondary
Number of Participants With Serious TEAEs
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants With TEAEs Leading to Discontinuation of Either Study Drug
Either study drug = avelumab only or talazoparib only. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Secondary
Number of Participants With TEAEs Leading to Discontinuation of All Study Drugs
All study drugs = all study drugs in the combination. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Secondary
Number of Participants With TEAEs Leading to Death
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Secondary
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
Secondary
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Secondary
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
Secondary
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. On-treatment period was defined as time from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. NCI-CTCAE criteria version 4.03 is used. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Count of Participants
Participants
From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
Secondary
Trough Concentrations (Ctrough)/Predose and Maximum Concentrations (Cmax) of Serum Avelumab Concentrations (μg/mL) by Visit (Excluding Site 1055)
Pharmacokinetics (PK) data analyses included descriptive summary statistics of the pre-dose/Ctrough concentrations for both investigational products and post-dose (for talazoparib) or Cmax concentrations (for avelumab) for each cycle.
The PK concentration analysis sets (1 unique set for each study drug used in the combination) were subsets of safety analysis set including participants with >=1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab/talazoparib. Cohorts were combined as pre-specified in reporting and analysis plan. Site 1055 was excluded as samples were not meeting the protocol requirements. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose/0 Hour (H) and 1 H on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2-4, and additionally on Day 1 of Cycles 6, 9, 12, 18, and 24.
ID
Title
Description
OG000
Phase 1b and Phase 2 Combined
Treatment = Avelumab 800 mg IV Infusion Q2W coadministered with Talazoparib 1 mg QD.
Units
Counts
Participants
Secondary
Predose and Postdose Plasma Talazoparib Concentrations (pg/mL) by Visit (Excluding Site 1055)
Pharmacokinetics (PK) data analyses included descriptive summary statistics of the pre-dose/Ctrough concentrations for both investigational products and post-dose (for talazoparib) or Cmax concentrations (for avelumab) for each cycle. Cmax=maximum concentration. Ctrough=trough concentration. Participants with moderate renal impairment were started at a lower, 0.75 mg QD, dose to compensate for decreased talazoparib clearance.
The PK concentration analysis sets (1 unique set for each study drug used in the combination) were subsets of safety analysis set including participants with >=1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab/talazoparib. Cohorts were combined as pre-specified in reporting and analysis plan. Site 1055 was excluded as samples were not meeting the protocol requirements. Here 'number analyzed' signifies participants evaluable for specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
Pre-dose and post-dose (at the end of the avelumab infusion) on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2-4.
ID
Title
Description
OG000
Talazoparib Starting Dose = 1 mg QD
Treatment = Avelumab 800 mg IV Infusion Q2W coadministered with Talazoparib 1 mg QD (participants with normal renal function or mild renal impairment).
OG001
Talazoparib Starting Dose = 0.75 mg QD
Secondary
Number of Participants With at Least 1 Valid Anti-drug Antibody (ADA) Result at: Any Time Point (N0), Baseline (N1), Baseline and Post-Baseline (N2), and Post-Baseline and Without Positive Baseline ADA Result (N3)
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline was defined as the last assessment prior to the date/time of the first dose of avelumab. N0, N1, N2, and N3=Number of participants with at least 1 valid ADA result at any time point, baseline (pre-dose on Day 1), baseline and post-baseline, and post-baseline, respectively.
The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least 1 ADA/Nab sample collected for avelumab. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Pre-dose (within 2 hours of talazoparib dose) on Day 1 and Day 15 of Cycle 1, on Day 1 of Cycle 2-4 and then on Day 1 of Cycles 6, 9, 12, 18, 24, and at the end of treatment (EOT)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants by ADA Categories
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline was defined as the last assessment prior to the date/time of the first dose of avelumab. N0, N1, N2, and N3=Number of participants with at least 1 valid ADA Result at any time point, baseline (pre-dose on Day 1), baseline and post-baseline, and post-baseline, respectively. n=number of participants in each category.
The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least 1 ADA/Nab sample collected for avelumab. Cohorts in Phase 2 were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Pre-dose (within 2 hours of talazoparib dose) on Day 1 and Day 15 of Cycles 1, on Day 1 of Cycle 2-4 and then on Day 1 of Cycles 6, 9, 12, 18, 24, and at the end of treatment (EOT)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2
Secondary
Phase 1b: Percentage of Participants With Confirmed OR as Per RECIST v1.1 and PCWG3 by Investigator Assessment
This OM is reported for participants in Phase 1b; OR was defined as the proportion of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 and with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis <10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-PD.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 1b arm only.
Posted
Number
95% Confidence Interval
Percentage of Particpants
From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 1b: Time to Response (TTR) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, TTR was defined for participants with confirmed OR (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC, TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a best overall response (BOR) of CR or PR as assessed by Investigator using RECIST v1.1.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 1b arm only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment to the first documentation of objective tumor response/the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression (<=5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 2: TTR in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, TTR was defined for participants with confirmed OR (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC, TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a best overall response (BOR) of CR or PR as assessed by Investigator using RECIST v1.1.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 2 only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment to the first documentation of objective tumor response/the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression (<= 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Secondary
Phase 2: Duration of Response (DR) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, DR was defined for participants with confirmed OR (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 2 only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure; Cohorts without evaluable participants for this outcome measure [i.e., Phase 2: Cohort E1 (mCRPC), Phase 2: Cohort E2 (mCRPC DDR+), Phase 2: Cohort F (BRCA/ATM-mutated)] are not presented.
Posted
Median
95% Confidence Interval
Months
From the first objective tumor response/soft tissue response to the first objective tumor progression/subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first (<=5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Secondary
Phase 1b: Progression-Free Survival (PFS) in Participants With Confirmed CR or PR
For participants with solid tumors except mCRPC, PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC, PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using RECIST v1.1, in bone as assessed by Investigator using PCWG3, or death, whichever occurred first
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 1b only.
Posted
Median
95% Confidence Interval
Months
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally QD in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Secondary
Phase 2: PFS in Participants With Confirmed CR or PR (RECIST v1.1)
This OM is reported for participants with solid tumors except mCRPC; for those participants, PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 2 only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 2: PFS in Participants With Confirmed CR or PR (RECIST v1.1 and PCWG3)
This OM was reported for participants with mCRPC; for these participants, PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using RECIST v1.1, in bone as assessed by Investigator using PCWG3, or death, whichever occurred first.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 2 only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From the first dose of study treatment to the date of disease progression/radiographic progression in soft tissue or bone, or death due to any cause, whichever occurred first (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 2: Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC
Time to PSA progression for participants with mCRPC was defined as the time from the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Phase 2 only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 1b: Overall Survival
Overall survival (OS) was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was for Phase 1b only.
Posted
Median
95% Confidence Interval
Months
From the first dose of study treatment to the date of death (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG000
Secondary
Phase 2: Overall Survival
OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was for Phase 2 only.
Posted
Median
95% Confidence Interval
Months
From the first dose of study treatment to the date of death (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Secondary
Phase 2: Percentage of Participants With PSA Response
PSA response was defined as the proportion of participants with confirmed PSA decline >=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must be confirmed by a second consecutive value at least 3 weeks later.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was planned for Cohorts E1, E2, and F in Phase 2 only as pre-specified in reporting and analysis plan. Cohorts without evaluable participants for this outcome measure [ie, Phase 2: Cohort F (BRCA/ATM-mutated)] are not presented.
Posted
Number
95% Confidence Interval
Percentage of Participants
From baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50% (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Phase 1b: Percentage of Participants With CA-125 Response
Cancer Antigen 125 (CA-125) response is defined as at least a 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was for Phase 1b only. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
From baseline to at least a 50% reduction in CA-125 level (maximum up to 5.2 years approximately)
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG000
Secondary
Phase 2: Percentage of Participants With CA-125 Response
CA-125 response is defined as at least a 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.
The FAS included all enrolled participants who received at least 1 dose of study treatment. Data for this OM was for Cohorts C1 and C2 in Phase 2 only as pre-specified in reporting and analysis plan.
Posted
Number
95% Confidence Interval
Percentage of Participants
From baseline to at least a 50% reduction in CA-125 level (maximum up to 5.2 years approximately)
ID
Title
Description
OG000
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants With Different Programmed Death-Ligand 1 (PD-L1) Status at Baseline
PD-L1 expression on tumor and infiltrating immune cells were measured by immunohistochemistry (IHC). PD-L1 expression level corresponds to the percentage of positive cells. The PD-L1 Positive category does not apply to cohorts A1 and A2. The PD-L1 High/Low categories only apply to cohorts A1 and A2. Participants were considered positive if their baseline tumor tissue sample demonstrated cell surface PD-L1 expression: 1) for Cohorts E1, E2, and F: >=1% tumor cells (TC) or >= 5% immune cells (IC); 2) for Cohort D: TC/IC>=25%; 3) for Cohorts B1, B2, C1, C2: IC>=5%; otherwise were considered negative. Categories based on PD-L1 expression level ≥50% and <50% were defined as High and Low, respectively.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this outcome measure was presented for Phase 2 only as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants With Different Tumor Mutational Burden (TMB) at Baseline
TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. High: TMB score >=20 muts/mb (number of mutations per megabase of DNA); Medium: TMB score >=10 muts/mb and <20 muts/mb; Low: TMB score <10 muts/mb.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this outcome measure was presented for Phase 2 only as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Secondary
Number of Participants With Different DNA Damage Repair (DDR) Status at Baseline
DDR defect positive was determined by presence of one or more pathogenic or likely pathogenic mutations in tissue, DNA and/or blood samples.
The full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Data for this outcome measure was presented for Phase 2 only as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
At baseline (the last available assessment prior to the start of study treatment was defined as 'baseline' value or 'baseline' assessment)
ID
Title
Description
OG000
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Time Frame
All-cause mortality: From start of the treatment up to 90 days post last dose of study treatment (maximum of 5.2 years approximately), TEAEs and Serious TEAEs: from first dose of any study treatment and up to 30 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first (maximum of 5.2 years approximately).
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Participants with locally advanced or metastatic solid tumors were treated with talazoparib 1.0 mg orally once daily (QD) in combination with avelumab 800 mg intravenously (IV) every 2 weeks (Q2W) for a maximum of 246.3 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
6
12
1
12
12
12
EG001
Phase 2: Cohort A1 (NSCLC)
Participants with locally advanced (primary or recurrent) or metastatic non-small cell lung cancer (NSCLC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
33
42
16
42
41
42
EG002
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
3
5
2
5
5
5
EG003
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
16
22
7
22
21
22
EG004
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
16
23
5
23
22
23
EG005
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
11
20
9
20
20
20
EG006
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
6
11
2
11
10
11
EG007
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
26
40
16
40
38
40
EG008
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
16
21
5
21
21
21
EG009
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
14
18
9
18
16
18
EG010
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
7
9
4
9
9
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG0033 affected22 at risk
EG0042 affected23 at risk
EG0050 affected20 at risk
EG0060 affected11 at risk
EG0073 affected40 at risk
EG0080 affected21 at risk
EG0090 affected18 at risk
EG0101 affected9 at risk
Autoimmune neutropenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Glucocorticoid deficiency
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Disease progression
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Face oedema
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Suprapubic pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hyphaema
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Haemorrhage urinary tract
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0008 affected12 at risk
EG00128 affected42 at risk
EG0024 affected5 at risk
EG00318 affected22 at risk
EG00410 affected23 at risk
EG00512 affected20 at risk
EG0067 affected11 at risk
EG00731 affected40 at risk
EG00815 affected21 at risk
EG00910 affected18 at risk
EG0105 affected9 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0017 affected42 at risk
EG0020 affected5 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0020 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0007 affected12 at risk
EG00110 affected42 at risk
EG0022 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0005 affected12 at risk
EG00115 affected42 at risk
EG0021 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hypophosphatasia
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Glucocorticoid deficiency
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Immune-mediated hypothyroidism
Endocrine disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Diplopia
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0018 affected42 at risk
EG0020 affected5 at risk
EG003
Chest pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
Chills
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0005 affected12 at risk
EG0017 affected42 at risk
EG0020 affected5 at risk
EG003
Facial pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG00117 affected42 at risk
EG0024 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Localised oedema
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0017 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0016 affected42 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0016 affected42 at risk
EG0023 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0018 affected42 at risk
EG0021 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG00114 affected42 at risk
EG0020 affected5 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Tongue discolouration
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Tongue pigmentation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0014 affected42 at risk
EG0020 affected5 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Localised infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0020 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0020 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0022 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0014 affected42 at risk
EG0020 affected5 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Amylase decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0013 affected42 at risk
EG0022 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0022 affected5 at risk
EG003
Blood albumin decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0019 affected42 at risk
EG0021 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Blood calcium decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0021 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0014 affected42 at risk
EG0020 affected5 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Blood urea increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Blood uric acid increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0021 affected5 at risk
EG003
International normalised ratio increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0014 affected42 at risk
EG0021 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0021 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Weight increased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0004 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG00118 affected42 at risk
EG0022 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0021 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0013 affected42 at risk
EG0020 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0012 affected42 at risk
EG0022 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0022 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0021 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0016 affected42 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0017 affected42 at risk
EG0021 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0020 affected5 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0020 affected5 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0018 affected42 at risk
EG0021 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0017 affected42 at risk
EG0020 affected5 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0021 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0018 affected42 at risk
EG0020 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0014 affected42 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG00117 affected42 at risk
EG0021 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0020 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0021 affected5 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0021 affected5 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0015 affected42 at risk
EG0020 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0021 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0013 affected42 at risk
EG0020 affected5 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0012 affected42 at risk
EG0020 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0011 affected42 at risk
EG0020 affected5 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected42 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000609138
avelumab
C586365
talazoparib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
16 subjects
FG00514 subjects
FG0067 subjects
FG00729 subjects
FG0089 subjects
FG00911 subjects
FG0105 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0091 subjects
FG0101 subjects
3 subjects
FG0053 subjects
FG0060 subjects
FG0072 subjects
FG0088 subjects
FG0094 subjects
FG0101 subjects
1 subjects
FG0051 subjects
FG0063 subjects
FG0074 subjects
FG0082 subjects
FG0092 subjects
FG0102 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
56.18
± 12.49
BG00453.83± 14.08
BG00562.65± 10.66
BG00661.36± 9.24
BG00765.73± 9.19
BG00863.71± 7.40
BG00971.56± 7.37
BG01063.00± 10.91
BG01163.17± 11.04
4
BG00315
BG00417
BG00512
BG0067
BG00716
BG0088
BG0093
BG0105
BG011108
65 - <75 years
Title
Measurements
BG0005
BG00119
BG0021
BG0036
BG0043
BG0055
BG0063
BG00716
BG00812
BG0098
BG0102
BG01180
75 - <85 years
Title
Measurements
BG0001
BG0017
BG0020
BG0031
BG0043
BG0053
BG0061
BG0077
BG0081
BG0096
BG0102
BG01132
>= 85 years
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
BG0100
BG0113
2
BG00322
BG00422
BG00520
BG00611
BG00714
BG0080
BG0090
BG0103
BG011106
Male
BG0009
BG00133
BG0023
BG0030
BG0041
BG0050
BG0060
BG00726
BG00821
BG00918
BG0106
BG011117
0
BG0030
BG0041
BG0050
BG0060
BG0072
BG0083
BG0091
BG0100
BG0117
Not Hispanic or Latino
BG00012
BG00139
BG0025
BG00319
BG00421
BG00518
BG00611
BG00738
BG00811
BG00916
BG0108
BG011198
Unknown or Not Reported
BG0000
BG0013
BG0020
BG0033
BG0041
BG0052
BG0060
BG0070
BG0087
BG0091
BG0101
BG01118
0
BG0030
BG0040
BG0050
BG0062
BG0071
BG0085
BG0092
BG0100
BG01114
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
Asian
Title
Measurements
BG0000
BG0015
BG0020
BG0031
BG0041
BG0050
BG0063
BG0072
BG0081
BG0092
BG0100
BG01115
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
White
Title
Measurements
BG0009
BG00134
BG0024
BG00320
BG00417
BG00518
BG0066
BG00736
BG00812
BG00914
BG0109
BG011179
Not reported
Title
Measurements
BG0000
BG0012
BG0020
BG0031
BG0044
BG0052
BG0060
BG0071
BG0083
BG0090
BG0100
BG01113
3
BG00314
BG00415
BG00510
BG0067
BG00715
BG00820
BG00911
BG0108
BG011124
Western Europe
BG0000
BG00110
BG0022
BG0030
BG0041
BG0052
BG0061
BG0075
BG0081
BG0094
BG0101
BG01127
Eastern Europe
BG0000
BG00119
BG0020
BG0036
BG0044
BG0055
BG0061
BG00716
BG0080
BG0091
BG0100
BG01152
Australasia
BG0000
BG0010
BG0020
BG0032
BG0042
BG0053
BG0060
BG0072
BG0080
BG0091
BG0100
BG01110
Asia
BG0000
BG0014
BG0020
BG0030
BG0041
BG0050
BG0062
BG0072
BG0080
BG0091
BG0100
BG01110
5
BG0021
BG00312
BG00412
BG0059
BG0068
BG00716
BG0084
BG0096
BG0101
BG01178
1
BG0008
BG00137
BG0024
BG00310
BG00411
BG00511
BG0063
BG00724
BG00817
BG00912
BG0108
BG011145
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 183.6 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00042
OG0015
OG00222
OG00323
OG00420
OG00511
OG00640
OG0077
Title
Denominators
Categories
Title
Measurements
OG00016.7(7.0 to 31.4)
OG00120.0(0.5 to 71.6)
OG00218.2(5.2 to 40.3)
OG00334.8(16.4 to 57.3)
OG00420.0(5.7 to 43.7)
OG00563.6(30.8 to 89.1)
OG00615.0(5.7 to 29.8)
OG0070(0.0 to 41.0)
OG001
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00021
OG00118
OG0022
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 16.1)
OG00111.1(1.4 to 34.7)
OG00250.0(1.3 to 98.7)
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality TEAEs
Title
Measurements
OG00012
OG001207
Participants with treatment-related TEAEs
Title
Measurements
OG00011
OG001197
Phase 2
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality Grade >=3 TEAEs
Title
Measurements
OG0009
OG001156
Participants with treatment-related Grade >=3 TEAEs
Title
Measurements
OG0009
OG001120
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality serious TEAEs
Title
Measurements
OG0001
OG00175
Participants with treatment-related serious TEAEs
Title
Measurements
OG0001
OG00125
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality TEAEs leading to discontinuation of avelumab only
Title
Measurements
OG0000
OG0015
Participants with treatment-related TEAEs leading to discontinuation of avelumab only
Title
Measurements
OG0000
OG0014
Participants with all-causality TEAEs leading to discontinuation of talazoparib only
Title
Measurements
OG0001
OG0019
Participants with treatment-related TEAEs leading to discontinuation of talazoparib only
Title
Measurements
OG0001
OG0018
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality TEAEs leading to discontinuation of all study drugs
Title
Measurements
OG0001
OG00120
Participants with treatment-related TEAEs leading to discontinuation of all study drugs
Title
Measurements
OG0000
OG0011
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Participants with all-causality TEAEs leading to death
Title
Measurements
OG0000
OG00121
Participants with treatment-related TEAEs leading to death
Title
Measurements
OG0000
OG0011
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Activated partial thromboplastin time prolonged
ParticipantsOG00011
ParticipantsOG001143
Title
Measurements
OG0004
OG00121
Anemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0008
OG001
Hemoglobin increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Lymphocyte count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0009
OG001
Lymphocyte count increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0001
OG001
Neutrophil count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0008
OG001
Platelet count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0006
OG001
White blood cell decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG00010
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Activated partial thromboplastin time prolonged
ParticipantsOG00011
ParticipantsOG001143
Title
Measurements
OG0000
OG0011
Anemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0004
OG001
Lymphocyte count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0004
OG001
Neutrophil count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0005
OG001
Platelet count decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0004
OG001
White blood cell decreased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0003
OG001
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Alanine aminotransferase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0001
OG00141
Alkaline phosphatase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0003
OG001
Aspartate aminotransferase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0002
OG001
Blood bilirubin increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Creatinine Phosphokinase (CPK) increased
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0002
OG001
Creatinine increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0009
OG001
Gamma-glutamyl transferase (GGT) increased
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0002
OG001
Hypercalcemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0001
OG001
Hyperglycemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hyperkalemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0002
OG001
Hypermagnesemia
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0000
OG001
Hypernatremia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypoalbuminemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0002
OG001
Hypocalcemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0001
OG001
Hypoglycemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypokalemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0003
OG001
Hypomagnesemia
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0002
OG001
Hyponatremia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0004
OG001
Hypophosphatemia
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0002
OG001
Lipase increased
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0004
OG001
Serum amylase increased
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0002
OG001
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
Alanine aminotransferase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG0012
Alkaline phosphatase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Aspartate aminotransferase increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Blood bilirubin increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Creatinine Phosphokinase (CPK) increased
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0000
OG001
Creatinine increased
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Gamma-glutamyl transferase (GGT) increased
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0000
OG001
Hyperglycemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hyperkalemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypermagnesemia
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0000
OG001
Hypoalbuminemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypocalcemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypokalemia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hyponatremia
ParticipantsOG00012
ParticipantsOG001208
Title
Measurements
OG0000
OG001
Hypophosphatemia
ParticipantsOG00012
ParticipantsOG001206
Title
Measurements
OG0001
OG001
Lipase increased
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0000
OG001
Serum amylase increased
ParticipantsOG00012
ParticipantsOG001207
Title
Measurements
OG0000
OG001
OG000194
Title
Denominators
Categories
Cycle 1 / Day 1 (0 Hour [H])
ParticipantsOG000194
Title
Measurements
OG000NA± NAThe result was Not Available as no observations were above the avelumab LLQ of 0.2 μg/mL.
Cycle 1 / Day 1 (1 H)
ParticipantsOG000178
Title
Measurements
OG000221.0± 41
Cycle 1 / Day 15 (0 H)
ParticipantsOG000183
Title
Measurements
OG00021.20± 72
Cycle 1 / Day 15 (1 H)
ParticipantsOG000164
Title
Measurements
OG000206.6± 86
Cycle 2 / Day 1 (0 H)
ParticipantsOG000168
Title
Measurements
OG00026.41± 68
Cycle 2 / Day 1 (1 H)
ParticipantsOG000156
Title
Measurements
OG000199.6± 110
Cycle 3 / Day 1 (0 H)
ParticipantsOG000120
Title
Measurements
OG00031.45± 80
Cycle 3 / Day 1 (1 H)
ParticipantsOG000126
Title
Measurements
OG000188.8± 105
Cycle 4 / Day 1 (0 H)
ParticipantsOG000106
Title
Measurements
OG00034.59± 81
Cycle 4 / Day 1 (1 H)
ParticipantsOG000114
Title
Measurements
OG000190.6± 99
Cycle 6 / Day 1 (0 H)
ParticipantsOG00078
Title
Measurements
OG00037.40± 73
Cycle 6 / Day 1 (1 H)
ParticipantsOG00081
Title
Measurements
OG000185.9± 98
Cycle 9 / Day 1 (0 H)
ParticipantsOG00040
Title
Measurements
OG00039.97± 91
Cycle 9 / Day 1 (1 H)
ParticipantsOG00044
Title
Measurements
OG000171.1± 145
Cycle 12 / Day 1 (0 H)
ParticipantsOG00018
Title
Measurements
OG00047.10± 63
Cycle 12 / Day 1 (1 H)
ParticipantsOG00018
Title
Measurements
OG000202.9± 88
Cycle 18 / Day 1 (0 H)
ParticipantsOG0003
Title
Measurements
OG00053.94± 33
Cycle 18 / Day 1 (1 H)
ParticipantsOG0003
Title
Measurements
OG000135.6± 354
Cycle 24 / Day 1 (0 H)
ParticipantsOG0001
Title
Measurements
OG00076.40± NAOnly 1 participant evaluable for this timepoint. Coefficient of variation is not applicable.
Cycle 24 / Day 1 (1 H)
ParticipantsOG0001
Title
Measurements
OG000378.0± NAOnly 1 participant evaluable for this timepoint. Coefficient of variation is not applicable.
Treatment = Avelumab 800 mg IV Infusion Q2W coadministered with Talazoparib 0.75 mg QD (participants with moderate renal impairment)
Units
Counts
Participants
OG000163
OG00131
Title
Denominators
Categories
Cycle 1 / Day 1 (Predose)
ParticipantsOG000163
ParticipantsOG00131
Title
Measurements
OG000NA± NAThe result was Not Available as no observations were above the talazoparib LLQ of 25 pg/mL.
OG001NA± NAThe result was Not Available as no observations were above the talazoparib LLQ of 25 pg/mL.
Cycle 1 / Day 1 (Postdose)
ParticipantsOG00046
ParticipantsOG00112
Title
Measurements
OG0002295± 137
OG001
Cycle 1 / Day 15 (Predose)
ParticipantsOG00072
ParticipantsOG00110
Title
Measurements
OG0004672± 63
OG001
Cycle 1 / Day 15 (Postdose)
ParticipantsOG00033
ParticipantsOG0013
Title
Measurements
OG0009055± 88
OG001
Cycle 2 / Day 1 (Predose)
ParticipantsOG00066
ParticipantsOG00110
Title
Measurements
OG0004385± 53
OG001
Cycle 2 / Day 1 (Postdose)
ParticipantsOG00021
ParticipantsOG0015
Title
Measurements
OG0008479± 73
OG001
Cycle 3 / Day 1 (Predose)
ParticipantsOG00047
ParticipantsOG0016
Title
Measurements
OG0004212± 46
OG001
Cycle 3 / Day 1 (Postdose)
ParticipantsOG00022
ParticipantsOG0013
Title
Measurements
OG0006765± 239
OG001
Cycle 4 / Day 1 (Predose)
ParticipantsOG00029
ParticipantsOG0016
Title
Measurements
OG0004713± 38
OG001
Cycle 4 / Day 1 (Postdose)
ParticipantsOG00015
ParticipantsOG0013
Title
Measurements
OG0006506± 76
OG001
OG001
Phase 2
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
N0
Title
Measurements
OG00012
OG001211
N1
Title
Measurements
OG00012
OG001209
N2
Title
Measurements
OG00011
OG001202
N3
Title
Measurements
OG00011
OG001200
All participants from Cohort A to Cohort F combined.
Units
Counts
Participants
OG00012
OG001211
Title
Denominators
Categories
ADA never-positive (n/N0)
Title
Measurements
OG00012
OG001205
ADA ever-positive (n/N0)
Title
Measurements
OG0000
OG0016
ADA ever-positive: Baseline ADA positive (n/N1) (No treatment-boosted ADA [n/N2])
Title
Measurements
OG0000
OG0014
ADA ever-positive: Treatment-induced ADA positive (n/N3)
Title
Measurements
OG0000
OG0012
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG00016.7(2.1 to 48.4)
Units
Counts
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG0001.8(1.8 to 1.8)
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG008
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG0007
OG0011
OG0024
OG0038
OG0044
OG0057
OG0066
OG0072
OG0081
Title
Denominators
Categories
Title
Measurements
OG0003.7(1.7 to 11.3)
OG0011.8(1.8 to 1.8)
OG0021.8(1.6 to 2.0)
OG0031.9(1.6 to 3.6)
OG0043.6(1.7 to 17.9)
OG0051.7(1.6 to 3.7)
OG0062.1(1.4 to 5.9)
OG0075.5(5.4 to 5.6)
OG0081.8(1.8 to 1.8)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG0007
OG0011
OG0024
OG0038
OG0044
OG0057
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG001NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG002NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG003NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG004NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG005NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
OG006NA(NA to NA)Median and 95% CI were not estimated for \<10 participants
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG0006.0(1.8 to 11.5)
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00042
OG0015
OG00222
OG00323
OG00420
OG00511
OG00640
OG0077
Title
Denominators
Categories
Title
Measurements
OG0004.7(3.7 to 7.4)
OG0011.9(1.8 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
OG0023.6(1.9 to 5.6)
OG0035.3(2.0 to 12.8)
OG0047.2(4.0 to 9.1)
OG00516.8(7.2 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
OG0063.6(1.9 to 5.4)
OG0071.7(1.4 to 3.3)
OG002
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00021
OG00118
OG0022
Title
Denominators
Categories
Title
Measurements
OG0004.1(1.9 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
OG0014.6(1.7 to 9.8)
OG0028.4(5.9 to 10.9)
OG002
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00021
OG00118
OG0022
Title
Denominators
Categories
Title
Measurements
OG0001.0(1.0 to 4.6)
OG0012.8(1.0 to 6.5)
OG0023.1(1.6 to 4.6)
12
Title
Denominators
Categories
Title
Measurements
OG00018.5(6.4 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG008
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG009
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00042
OG0015
OG00222
OG00323
OG00420
OG00511
OG00640
OG00721
OG00818
OG0099
Title
Denominators
Categories
Title
Measurements
OG00011.6(8.4 to 14.9)
OG00126.3(3.5 to 43.3)
OG0028.2(5.8 to 13.0)
OG00327.5(12.6 to 40.2)
OG00422.9(7.8 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
OG00538.8(16.9 to NA)Upper limit of 95% CI was not reached due to fewer number of participants with event.
OG00613.1(8.5 to 19.2)
OG00715.9(9.6 to 20.7)
OG00816.1(10.8 to 23.4)
OG0096.9(1.4 to 27.4)
Units
Counts
Participants
OG00021
OG00118
Title
Denominators
Categories
Title
Measurements
OG0009.5(1.2 to 30.4)
OG0015.6(0.1 to 27.3)
1
Title
Denominators
Categories
Title
Measurements
OG000100(2.5 to 100.0)
Units
Counts
Participants
OG00020
OG00111
Title
Denominators
Categories
Title
Measurements
OG00045.0(23.1 to 68.5)
OG00163.6(30.8 to 89.1)
OG001
Phase 2: Cohort A2 (NSCLC DDR+)
Participants with locally advanced (primary or recurrent) or metastatic NSCLC with DNA damage repair positive (DDR+) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 173.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG008
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG009
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00042
OG0015
OG00222
OG00323
OG00420
OG00511
OG00640
OG00721
OG00818
OG0099
Title
Denominators
Categories
High
Title
Measurements
OG0003
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Low
Title
Measurements
OG0008
OG0011
OG0020
OG003
Positive (Not applicable for Cohorts A1 and A2)
Title
Measurements
OG0000
OG0010
OG0028
OG003
Negative
Title
Measurements
OG00022
OG0012
OG0026
OG003
Unknown
Title
Measurements
OG0009
OG0011
OG0028
OG003
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG008
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG009
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
Units
Counts
Participants
OG00042
OG0015
OG00222
OG00323
OG00420
OG00511
OG00640
OG00721
OG00818
OG0099
Title
Denominators
Categories
High
Title
Measurements
OG0004
OG0011
OG0020
OG0030
OG0040
OG0050
OG0065
OG0070
OG0082
OG0090
Medium
Title
Measurements
OG0009
OG0011
OG0023
OG003
Low
Title
Measurements
OG00013
OG0013
OG00212
OG003
Unknown
Title
Measurements
OG00016
OG0010
OG0027
OG003
OG002
Phase 2: Cohort B1 (TNBC)
Participants with locally advanced (primary or recurrent) or triple-negative breast cancer (TNBC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 93.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG003
Phase 2: Cohort B2 (BC HR+ HER2- DDR+)
Participants with locally advanced (primary or recurrent) or metastatic hormone receptor positive (HR+)/herman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 180.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG004
Phase 2: Cohort C1 (OVC)
Participants with locally advanced (primary or recurrent) or metastatic ovarian cancer (OVC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 161.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG005
Phase 2: Cohort C2 (OVC BRCA-mutated)
Participants with locally advanced (primary or recurrent) or metastatic OVC with germline or somatic BRCA1 or BRCA2 gene defect were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 144.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG006
Phase 2: Cohort D (UC)
Participants with locally advanced (primary or recurrent) or metastatic urothelial cancer (UC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 164.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG007
Phase 2: Cohort E1 (mCRPC)
Participants with metastatic castration-resistant prostate cancer (mCRPC) were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 54.1 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG008
Phase 2: Cohort E2 (mCRPC DDR+)
Participants with mCRPC with DDR+ were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 74.0 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.
OG009
Phase 2: Cohort F (BRCA/ATM-mutated)
Participants with locally advanced (primary or recurrent) or metastatic solid tumors, independent of tissue of origin, with previously identified pathogenic, or likely pathogenic, germline or somatic defects in BRCA1, BRCA2, or ATM genes were treated with talazoparib 1 mg QD orally in combination with avelumab 800 mg IV Q2W for a maximum of 49.9 weeks. Safety follow-up was for 90 days after last dose of study treatment or until time of initiation of new anticancer treatment, whichever comes first.