Basket Study to Evaluate the Therapeutic Activity of Siml... | NCT03386721 | Trialant
NCT03386721
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Feb 21, 2023Actual
Enrollment
256Actual
Phase
Phase 2
Conditions
Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
Interventions
simlukafusp alfa
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Gemcitabine
Vinorelbine
Countries
United States
Belgium
France
Germany
Israel
New Zealand
Poland
Russia
Singapore
South Korea
Spain
Switzerland
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03386721
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP40234
Secondary IDs
ID
Type
Description
Link
2017-003182-94
EudraCT Number
Brief Title
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
Official Title
An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Feb 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.
Expanded Access Info
No
Start Date
Feb 19, 2018Actual
Primary Completion Date
Dec 30, 2021Actual
Completion Date
Dec 30, 2021Actual
First Submitted Date
Dec 22, 2017
First Submission Date that Met QC Criteria
Dec 22, 2017
First Posted Date
Dec 29, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 23, 2022
Results First Submitted that Met QC Criteria
Feb 20, 2023
Results First Posted Date
Feb 21, 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
Feb 20, 2023
Last Update Posted Date
Feb 21, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
256Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A (Part I)
Experimental
Checkpoint Inhibitor (CPI)-Naïve Participants with non-small-cell lung cancer (NSCLC) who have not received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: collection of fresh tumor biopsies (at baseline and on-treatment) will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort B (Part I)
Experimental
CPI-Experienced Participants (NSCLC) who have received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort C (Part I)
Experimental
This is a mandatory biopsy cohort based on the treatment's safety and preliminary activity analysis to enroll CPI-Naive Participants. Participants (NSCLC) will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
simlukafusp alfa
Drug
simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.
Cohort A (Part I)
Cohort B (Part I)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
Measurable disease, as defined by RECIST Version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
Life expectancy of >=12 weeks
Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.
Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.
Consent to provide an archival tumor tissue sample (if available, applicable to all participants)
Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamics (PD) biomarker analysis (biopsies are optional for Cohort A)
Adequate cardiovascular function as defined in the study protocol
AEs related to any previous radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
Adequate haematological, liver, and renal functions.
Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:
NYHA Class 1
Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.
Participants with Gilbert's syndrome will be eligible for the study
Participants must have had confirmed diagnosis of recurrent or metastatic squamous cell carcinoma head and neck, or esophageal cancer or metastatic, persistent or recurrent squamous cervical cancer.
Exclusion Criteria:
Symptomatic or untreated central nervous system (CNS) metastases
History of treated asymptomatic CNS metastases as described in the protocol
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks before enrollment
Leptomeningeal disease
An active second malignancy
Penetrating tumor infiltration
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration
History of significant vascular disease (for example, aortic aneurysm, aortic dissection)
Active or uncontrolled infections
Human immunodeficiency virus (HIV) or Active Hepatitis A, B, C, D or E infection (HAV/HBV/HCV/HDV/HEV).
Severe infection within 4 weeks before study treatment administration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
History of chronic liver disease or evidence of hepatic cirrhosis
Dementia or altered mental status that would prohibit informed consent
History of, active or suspicion of autoimmune disease
History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Bilateral pleural effusion confirmed by X-ray
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Concurrent therapy with any other investigational drug
Immunomodulating agents as described in study protocol
Chronic use of steroids
Last dose with any cytostatic treatments < 28 days before study treatment administration
Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
Major surgery or significant traumatic injury <28 days before study treatment administration (excluding fine needle biopsies) or if wound healing has not completed after surgery or anticipation of the need for major surgery during study treatment
Known hypersensitivity to any of the components of the simlukafusp alfa drug product or atezolizumab drug product
Severe dyspnea at rest or requiring supplementary oxygen therapy Locally curative options are available for participant's disease.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
Verlingue L, Italiano A, Prenen H, Guerra Alia EM, Tosi D, Perets R, Lugowska I, Moiseyenko V, Gumus M, Arslan C, Lindsay CR, Deva S, Taus A, Oaknin A, Rottey S, Cicin I, Goksu SS, Smolin A, Rosello-Keranen S, Habigt C, Marbach D, Boetsch C, Dejardin D, Sleiman N, Evers S, Richard M, Ardeshir C, Charo J, Kraxner A, Teichgraber V, Keshelava N, Dziadziuszko R. Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. EBioMedicine. 2024 Nov;109:105374. doi: 10.1016/j.ebiom.2024.105374. Epub 2024 Oct 11.
A total of 256 participants were enrolled. 95 participants in non-small cell lung cancer (NCSLC) cohorts [Part I: A, B, D, F & Part II: E] & 161 participants in squamous cell carcinoma (SCC) cohort (78 with head and neck SCC (HNSCC) [Part III: G, H, K], 35 in esophageal SCC (ESCC) [Part 3: I and M], & 48 in cervical SCC (CSCC) [Part 3 J & N] received simlukafusp alfa & atezolizumab. No participants were enrolled in Cohorts C & L as emerging data did not lead to the need to open these cohorts.
Recruitment Details
Participants took part in the study at 42 investigative sites in Belgium, France, Germany, Israel, Korea, New Zealand, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, USA from 19 February 2018 to 30 December 2021
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
NSCLC: Part I Cohort A (QW/Q2W)
Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Dec 21, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort D Arm I (Part I)
Experimental
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.
Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort D Arm 2 (Part I)
Experimental
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel.
Participants will receive simlukafusp alfa intravenous (IV) infusion once in 3 weeks (Q3W) up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q3W at a dose of 1200 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort D Arm 3 (Part I)
Experimental
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel will receive a single-agent gemcitabine or vinorelbine as per approved protocol.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: Gemcitabine
Drug: Vinorelbine
Cohort E Arm I (Part II)
Experimental
This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort E Arm 2 (Part II)
Experimental
This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa IV infusion in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.
Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort F (Part I)
Experimental
CPI-experienced, docetaxel naive participants (NSCLC) who experienced disease progression during or following treatment with a platinum - containing regimen. Participants will receive combination of simlukafusp alfa and atezolizumab in a Q3W schedule. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg.
Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort G (Part III)
Experimental
CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort G Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort H (Part III)
Experimental
Previously treated, CPI-experienced squamous cell carcinoma head and heck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort H Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort I (Part III)
Experimental
Previously treated, CPI-naïve squamous esophageal cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort I Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort J (Part III)
Experimental
Previously treated, CPI-naïve squamous cervical cancer (20 response evaluable participants): mandatory biopsy. Participants in cohort J Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort K (Part III)
Experimental
CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort K Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort L (Part III)
Experimental
Previously treated, CPI-experienced squamous cell carcinoma head and neck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort L Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort M (Part III)
Experimental
Esophageal SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort N (Part III)
Experimental
Cervical SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa
Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cohort C (Part I)
Cohort D Arm 2 (Part I)
Cohort D Arm I (Part I)
Cohort E Arm 2 (Part II)
Cohort E Arm I (Part II)
Cohort F (Part I)
Cohort G (Part III)
Cohort H (Part III)
Cohort I (Part III)
Cohort J (Part III)
Cohort K (Part III)
Cohort L (Part III)
Cohort M (Part III)
Cohort N (Part III)
RO6874281
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Drug
Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.
Cohort A (Part I)
Cohort B (Part I)
Cohort C (Part I)
Cohort D Arm 2 (Part I)
Cohort D Arm I (Part I)
Cohort E Arm 2 (Part II)
Cohort E Arm I (Part II)
Cohort F (Part I)
Cohort G (Part III)
Cohort H (Part III)
Cohort I (Part III)
Cohort J (Part III)
Cohort K (Part III)
Cohort L (Part III)
Cohort M (Part III)
Cohort N (Part III)
Gemcitabine
Drug
Single-agent treatment administered as per approved protocol.
Cohort D Arm 3 (Part I)
Vinorelbine
Drug
Single-agent treatment administered as per approved protocol.
Cohort D Arm 3 (Part I)
Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Duration of Response (DoR) According to RECIST Version 1.1
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
Progression-Free Survival (PFS) According to RECIST Version 1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
From first dose of study treatment up to death due to any cause (up to approximately 47 months)
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Baseline up to end of the study (up to approximately 47 months)
Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
Baseline
Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
Baseline up 2 months
Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
Baseline up to 2 months
Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan
704
Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei
100
Taiwan
Adana Baskent University Hospital; Medical Oncology
Adana
01120
Turkey (Türkiye)
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya
07070
Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne
22030
Turkey (Türkiye)
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
Istanbul
34098
Turkey (Türkiye)
?zmir Medical Park; Onkoloji
Izmir
Turkey (Türkiye)
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy
34722
Turkey (Türkiye)
Barts
London
EC1M6BQ
United Kingdom
University College London Hospital
London
N7 9NH
United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester
M2O 4BX
United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton
SM2 5PT
United Kingdom
Derived
Prenen H, Deva S, Keam B, Lindsay CR, Lugowska I, Yang JC, Longo F, de Miguel M, Ponz-Sarvise M, Ahn MJ, Gumus M, Champiat S, Italiano A, Salas S, Perets R, Arslan C, Cho BC, Evers S, Boetsch C, Marbach D, Dejardin D, Sleiman N, Ardeshir C, Richard M, Charo J, Kraxner A, Keshelava N, Teichgraber V, Moreno V. Phase II Study to Determine the Antitumor Activity and Safety of Simlukafusp Alfa (FAP-IL2v) Combined with Atezolizumab in Esophageal Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2945-2953. doi: 10.1158/1078-0432.CCR-23-2677.
FG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
FG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
FG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
FG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
FG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
FG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
FG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
FG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
FG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
FG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
FG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
FG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
FG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
FG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
FG00026 subjects
FG00132 subjects
FG0023 subjects
FG0035 subjects
FG0042 subjects
FG00522 subjects
FG0063 subjects
FG0072 subjects
FG00823 subjects
FG00930 subjects
FG01033 subjects
FG01147 subjects
FG01225 subjects
FG0132 subjects
FG0141 subjects
Response Evaluable Population
Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
FG00026 subjects
FG00132 subjects
FG0023 subjects
FG0035 subjects
FG0040 subjects
FG00521 subjects
FG0063 subjects
FG0072 subjects
FG00822 subjects
FG00928 subjects
FG01032 subjects
FG01144 subjects
FG01225 subjects
FG0132 subjects
FG0141 subjects
COMPLETED
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0102 subjects
FG0116 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG00022 subjects
FG00131 subjects
FG0023 subjects
FG0035 subjects
FG0042 subjects
FG00521 subjects
FG0063 subjects
FG0072 subjects
FG00822 subjects
FG00930 subjects
FG01031 subjects
FG01141 subjects
FG01225 subjects
FG0132 subjects
FG0141 subjects
Type
Comment
Reasons
Death
FG00012 subjects
FG00121 subjects
FG0022 subjects
FG0035 subjects
FG0041 subjects
FG00512 subjects
FG0061 subjects
FG0071 subjects
FG00812 subjects
FG00920 subjects
FG01021 subjects
FG01121 subjects
FG01214 subjects
FG0132 subjects
FG0141 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Reason not specified
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0005 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Symptomatic Deterioration
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants who received at least one dose of study treatment, whether or not prematurely withdrawn from the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
BG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
BG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
BG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
BG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
BG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
BG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
BG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
BG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
BG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
BG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
BG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
BG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
BG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
BG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00132
BG0023
BG0035
BG0042
BG00522
BG0063
BG0072
BG00823
BG00930
BG01033
BG01147
BG01225
BG0132
BG0141
BG015256
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
Title
Measurements
BG00058.0± 10.5
BG00159.8± 9.9
BG00263.7± 3.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00110
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG0011
BG002
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
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to disease progression or study treatment discontinuation (up to 38 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG00026
OG00132
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00019.2(8.51 to 37.88)
OG0016.3(1.73 to 20.15)
OG0020(0.00 to 56.15)
OG003
Secondary
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to disease progression or study treatment discontinuation (up to 38 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
Secondary
Duration of Response (DoR) According to RECIST Version 1.1
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Data was not collected for this outcome measure due to premature termination of the study by the sponsor.
Posted
From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
Secondary
Progression-Free Survival (PFS) According to RECIST Version 1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
Posted
Median
95% Confidence Interval
months
Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
Secondary
Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
Posted
Median
95% Confidence Interval
months
From first dose of study treatment up to death due to any cause (up to approximately 47 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
Secondary
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Safety Population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
Posted
Number
percentage of participants
Baseline up to end of the study (up to approximately 47 months)
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
Secondary
Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact.
Posted
Baseline
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
Secondary
Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis.
Posted
Baseline up 2 months
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
Secondary
Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis.
Posted
Baseline up to 2 months
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
Secondary
Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods
Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact.
Posted
Baseline up to 2 months
ID
Title
Description
OG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
Time Frame
Baseline up to end of the study (up to approximately 47 months)
Description
Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
NSCLC: Part I Cohort A (QW/Q2W)
CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
12
26
13
26
25
26
EG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
21
32
25
32
32
32
EG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
3
3
0
3
3
3
EG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
5
5
3
5
5
5
EG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
1
2
2
2
2
2
EG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
12
22
14
22
21
22
EG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
1
3
1
3
3
3
EG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
1
2
1
2
2
2
EG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
14
23
15
23
23
23
EG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
20
30
22
30
29
30
EG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
21
33
20
33
33
33
EG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
21
47
32
47
47
47
EG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
14
25
14
25
24
25
EG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
2
2
1
2
2
2
EG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
1
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected2 at risk
EG0051 events1 affected22 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected2 at risk
EG0081 events1 affected23 at risk
EG0093 events2 affected30 at risk
EG0100 events0 affected33 at risk
EG0113 events2 affected47 at risk
EG0122 events2 affected25 at risk
EG0130 events0 affected2 at risk
EG0140 events0 affected1 at risk
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MYOCARDITIS
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TRACHEO-OESOPHAGEAL FISTULA
Congenital, familial and genetic disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ADDISON'S DISEASE
Endocrine disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
IMMUNE-MEDIATED HYPOPHYSITIS
Endocrine disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GASTRIC HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
IMMUNE-MEDIATED ENTEROCOLITIS
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LARGE INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MOUTH HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OESOPHAGEAL FISTULA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OESOPHAGEAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OESOPHAGEAL STENOSIS
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CHILLS
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
FACIAL PAIN
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GENERALISED OEDEMA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFLAMMATION
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MALAISE
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MEDICAL DEVICE SITE HAEMORRHAGE
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PAIN
General disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PERFORMANCE STATUS DECREASED
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0014 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BILIARY OBSTRUCTION
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DRUG-INDUCED LIVER INJURY
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEPATOTOXICITY
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ANAPHYLACTIC SHOCK
Immune system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SYSTEMIC IMMUNE ACTIVATION
Immune system disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL WALL ABSCESS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ASPERGILLUS INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CORNEAL INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ENCEPHALITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ESCHERICHIA INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LYMPH GLAND INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PELVIC INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PERITONEAL ABSCESS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PLEURAL INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA BACTERIAL
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA NECROTISING
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PULMONARY SEPSIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SEPSIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INCORRECT DOSE ADMINISTERED
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG00117 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MEDICATION ERROR
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
UROSTOMY COMPLICATION
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VASCULAR ACCESS COMPLICATION
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LIVER FUNCTION TEST INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OXYGEN SATURATION DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TYPE 1 DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PATHOLOGICAL FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
AGNOSIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
APHASIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CEREBRAL ISCHAEMIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ENCEPHALOPATHY
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
POLYNEUROPATHY
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VOCAL CORD PARALYSIS
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DEVICE DISLOCATION
Product Issues
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEPHRITIS
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PYELOCALIECTASIS
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
FEMALE GENITAL TRACT FISTULA
Reproductive system and breast disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LARYNGEAL HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PHARYNGEAL HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
STEVENS-JOHNSON SYNDROME
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MEDICAL DEVICE REMOVAL
Surgical and medical procedures
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CAPILLARY LEAK SYNDROME
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0003 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VASCULITIS
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG00118 events11 affected32 at risk
EG0020 events0 affected3 at risk
EG0033 events1 affected5 at risk
EG0040 events0 affected2 at risk
EG0057 events5 affected22 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected2 at risk
EG00829 events15 affected23 at risk
EG00913 events9 affected30 at risk
EG0108 events7 affected33 at risk
EG01140 events23 affected47 at risk
EG01229 events11 affected25 at risk
EG0130 events0 affected2 at risk
EG0140 events0 affected1 at risk
COAGULOPATHY
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LYMPHOCYTOSIS
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0017 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0005 events3 affected26 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GLUCOCORTICOID DEFICIENCY
Endocrine disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERTHYROIDISM
Endocrine disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0005 events5 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG00017 events9 affected26 at risk
EG00110 events9 affected32 at risk
EG0022 events2 affected3 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG00022 events11 affected26 at risk
EG00111 events10 affected32 at risk
EG0022 events1 affected3 at risk
EG003
OESOPHAGEAL PAIN
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 23.1
Systematic Assessment
EG00024 events10 affected26 at risk
EG00110 events7 affected32 at risk
EG0023 events1 affected3 at risk
EG003
ASTHENIA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0009 events6 affected26 at risk
EG0018 events7 affected32 at risk
EG0023 events2 affected3 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CHILLS
General disorders
MedDRA version 23.1
Systematic Assessment
EG00023 events12 affected26 at risk
EG00123 events12 affected32 at risk
EG0021 events1 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA version 23.1
Systematic Assessment
EG00025 events14 affected26 at risk
EG00121 events15 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERTHERMIA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MALAISE
General disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected3 at risk
EG003
OEDEMA
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 23.1
Systematic Assessment
EG0006 events6 affected26 at risk
EG0017 events4 affected32 at risk
EG0021 events1 affected3 at risk
EG003
PAIN
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0014 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA version 23.1
Systematic Assessment
EG000197 events20 affected26 at risk
EG00191 events29 affected32 at risk
EG00211 events3 affected3 at risk
EG003
XEROSIS
General disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEPATOTOXICITY
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected3 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected3 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RHINITIS
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0003 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0005 events3 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG00011 events4 affected26 at risk
EG00116 events7 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG00024 events9 affected26 at risk
EG00112 events9 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG00027 events12 affected26 at risk
EG00113 events8 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BILIRUBIN CONJUGATED INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0009 events4 affected26 at risk
EG0014 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG00015 events6 affected26 at risk
EG00111 events6 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0006 events3 affected26 at risk
EG0017 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BLOOD URIC ACID INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
EOSINOPHIL COUNT INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0005 events5 affected26 at risk
EG0019 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0008 events2 affected26 at risk
EG0016 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0003 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0008 events3 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0007 events6 affected26 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected3 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG00011 events7 affected26 at risk
EG00116 events12 affected32 at risk
EG0023 events2 affected3 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0005 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0009 events4 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG00014 events3 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 23.1
Systematic Assessment
EG00012 events5 affected26 at risk
EG00115 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG0016 events5 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0008 events7 affected26 at risk
EG0014 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0003 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0013 events2 affected32 at risk
EG0021 events1 affected3 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0014 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0008 events4 affected26 at risk
EG0016 events4 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NEUROTOXICITY
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected3 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events4 affected26 at risk
EG00111 events8 affected32 at risk
EG0022 events2 affected3 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0008 events6 affected26 at risk
EG00110 events7 affected32 at risk
EG0021 events1 affected3 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events3 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0004 events2 affected26 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected3 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG00011 events6 affected26 at risk
EG0018 events6 affected32 at risk
EG0022 events2 affected3 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG00026 events13 affected26 at risk
EG0015 events5 affected32 at risk
EG0021 events1 affected3 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA version 23.1
Systematic Assessment
EG0006 events2 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
CAPILLARY LEAK SYNDROME
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG00114 events11 affected32 at risk
EG0020 events0 affected3 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA version 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected3 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000594389
atezolizumab
D000093542
Gemcitabine
D000077235
Vinorelbine
Ancestor Terms
ID
Term
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D014748
Vinca Alkaloids
D046948
Secologanin Tryptamine Alkaloids
D026121
Indole Alkaloids
D000470
Alkaloids
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D054836
Indolizidines
D007212
Indolizines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0053 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0102 subjects
FG0116 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
1 subjects
FG0053 subjects
FG0060 subjects
FG0071 subjects
FG0084 subjects
FG0095 subjects
FG0103 subjects
FG01111 subjects
FG0126 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0103 subjects
FG0112 subjects
FG0123 subjects
FG0130 subjects
FG0140 subjects
65.6
± 4.3
BG00463.5± 4.9
BG00557.4± 8.9
BG00656.7± 0.6
BG00768.0± 2.8
BG00855.7± 12.8
BG00958.8± 8.2
BG01063.1± 9.6
BG01151.3± 11.2
BG01255.8± 11.7
BG01367.0± 15.6
BG01449.0± NASince only 1 participant was analyzed, the standard deviation (SD) could not be calculated.
BG01557.6± 10.8
1
BG0030
BG0041
BG00511
BG0061
BG0070
BG0085
BG0097
BG01010
BG01147
BG0126
BG0130
BG0141
BG015110
Male
BG00016
BG00122
BG0022
BG0035
BG0041
BG00511
BG0062
BG0072
BG00818
BG00923
BG01023
BG0110
BG01219
BG0132
BG0140
BG015146
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Asian
BG0009
BG0015
BG0020
BG0030
BG0040
BG0055
BG0061
BG0070
BG0083
BG0095
BG0106
BG0110
BG0125
BG0131
BG0140
BG01540
Native Hawaiian or Other Pacific Islander
BG0002
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0154
Black or African American
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0152
White
BG00015
BG00126
BG0023
BG0035
BG0042
BG00517
BG0062
BG0072
BG00819
BG00916
BG01022
BG01133
BG01218
BG0130
BG0141
BG015181
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0098
BG0105
BG01113
BG0122
BG0131
BG0140
BG01529
0
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0153
Not Hispanic or Latino
Title
Measurements
BG00023
BG00128
BG0023
BG0034
BG0042
BG00520
BG0063
BG0072
BG00822
BG00921
BG01027
BG01133
BG01223
BG0131
BG0141
BG015213
Not Stated
Title
Measurements
BG0001
BG0012
BG0020
BG0031
BG0040
BG0051
BG0060
BG0070
BG0081
BG0097
BG0104
BG0119
BG0122
BG0131
BG0140
BG01529
Unknown
Title
Measurements
BG0002
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0102
BG0115
BG0120
BG0130
BG0140
BG01511
5
OG0040
OG00521
OG0063
OG0072
OG00822
OG00928
OG01032
OG01144
OG01225
OG0132
OG0141
0
(0.00 to 43.45)
OG0054.8(0.85 to 22.67)
OG00666.7(20.77 to 93.85)
OG00750.0(9.45 to 90.55)
OG00818.2(7.31 to 38.52)
OG0093.6(0.63 to 17.71)
OG01021.9(11.02 to 38.75)
OG01127.3(16.35 to 41.85)
OG0124.0(0.71 to 19.54)
OG0130(0.00 to 65.76)
OG0140(0.00 to 79.35)
OG001
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG00026
OG00132
OG0023
OG0035
OG0040
OG00521
OG0063
OG0072
OG00822
OG00928
OG01032
OG01144
OG01225
OG0132
OG0141
Title
Denominators
Categories
Title
Measurements
OG00053.8(35.46 to 71.24)
OG00162.5(45.25 to 77.07)
OG0020(0.00 to 56.15)
OG00320.0(3.62 to 62.45)
OG00557.1(36.55 to 75.53)
OG00666.7(20.77 to 93.85)
OG00750.0(9.45 to 90.55)
OG00850.0(30.72 to 69.28)
OG00914.3(5.70 to 31.49)
OG01043.8(28.17 to 60.67)
OG01168.2(53.44 to 80.00)
OG01236.0(20.25 to 55.48)
OG01350.0(9.45 to 90.55)
OG0140(0.00 to 79.35)
NSCLC: Part I Cohort B (QW/Q2W)
CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG00026
OG00132
OG0023
OG0035
OG0040
OG00521
OG0063
OG0072
OG00822
OG00928
OG01032
OG01144
OG01225
OG0132
OG0141
Title
Denominators
Categories
Title
Measurements
OG0003.5(1.7 to 7.4)
OG0013.7(3.1 to 5.2)
OG0022.0(1.7 to NA)Upper limit of 95% confidence interval (CI) could not be calculated due to low number of participants with events.
OG0032.0(1.9 to NA)Upper limit of 95% CI could not be calculated due to low number of participants with events.
OG0053.5(1.9 to 5.5)
OG006NA(2.6 to NA)Median and Upper limit of 95% CI could not be calculated due to low number of participants with events.
OG00710.5(1.9 to NA)Upper limit of 95% CI could not be calculated due to low number of participants with events.
OG0082.5(1.8 to 5.6)
OG0091.9(1.8 to 1.9)
OG0101.9(1.8 to 3.7)
OG0113.7(3.3 to 9.0)
OG0121.9(1.6 to 3.2)
OG0132.6(1.6 to NA)Upper limit of 95% CI could not be calculated due to low number of participants with events.
OG0141.9(NA to NA)Upper and lower limit of 95% CI could not be calculated as only one participant with events was evaluated.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG00026
OG00132
OG0023
OG0035
OG0040
OG00521
OG0063
OG0072
OG00822
OG00928
OG01032
OG01144
OG01225
OG0132
OG0141
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG001NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG002NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG003NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG005NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG006NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG007NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG008NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG009NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG010NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG011NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG012NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG013NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG014NA(NA to NA)Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported.
OG002
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG00026
OG00132
OG0023
OG0035
OG0042
OG00522
OG0063
OG0072
OG00823
OG00930
OG01033
OG01147
OG01225
OG0132
OG0141
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
OG006100
OG007100
OG008100
OG009100
OG010100
OG011100
OG012100
OG013100
OG014100
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
OG003
NSCLC: Part I Cohort D, Arm 2 (Q3W)
CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
OG004
NSCLC: Part I Cohort D, Arm 3 (Q3W)
CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
OG005
NSCLC: Part I Cohort F (Q3W)
CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
OG006
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
OG007
NSCLC: Part II Cohort E, Arm 2 (Q3W)
NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
OG008
SCCHN: Part III Cohort G (Q3W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
OG009
SCCHN: Part III Cohort H (Q3W)
CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
OG010
ESCC: Part III Cohort I (Q3W)
CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
OG011
CSCC: Part III Cohort J (Q3W)
CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
OG012
SCCHN: Part III Cohort K (QW/Q2W)
CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
OG013
ESCC: Part III Cohort M (QW/Q2W)
Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
OG014
CSCC: Part III Cohort N (QW/Q2W)
Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.