A Study of SAR444245 Combined With Other Anticancer Thera... | NCT05104567 | Trialant
NCT05104567
Sponsor
Sanofi
Status
Completed
Last Update Posted
Sep 24, 2025Actual
Enrollment
138Actual
Phase
Phase 2
Conditions
Oesophageal Squamous Cell Carcinoma
Gastric Cancer
Hepatocellular Carcinoma
Colorectal Cancer
Oesophageal Adenocarcinoma
Interventions
THOR-707
Pembrolizumab
Cetuximab
Countries
United States
Belgium
Chile
China
France
Italy
Netherlands
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT05104567
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACT16902
Secondary IDs
ID
Type
Description
Link
U1111-1251-4981
Registry Identifier
ICTRP
MK-3475-B78
Other Identifier
Merck Sharp & Dohme LLC.
KEYNOTE-B78
Other Identifier
Merck Sharp & Dohme LLC.
2021-002181-41
EudraCT Number
Brief Title
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
Official Title
A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 9, 2021Actual
Primary Completion Date
Jul 26, 2023Actual
Completion Date
Sep 9, 2024Actual
First Submitted Date
Oct 21, 2021
First Submission Date that Met QC Criteria
Oct 21, 2021
First Posted Date
Nov 3, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2025
Results First Submitted that Met QC Criteria
Jun 25, 2025
Results First Posted Date
Jul 1, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 24, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 1, 2025Actual
Last Update Submitted Date
Sep 21, 2025
Last Update Posted Date
Sep 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.
Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens.
Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens.
Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).
Detailed Description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles {cohort A; B1,B2, B3, C and D1} = 735 days or until PD {cohort D2}], an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier.
Conditions Module
Conditions
Oesophageal Squamous Cell Carcinoma
Gastric Cancer
Hepatocellular Carcinoma
Colorectal Cancer
Oesophageal Adenocarcinoma
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
138Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: ESCC Post PD-1/PD-L1; SAR444245 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Experimental
Participants with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC), regardless of programmed cell death-ligand 1 (PD-L1) expression (any combined positive score [CPS]), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-programmed cell death-1 (PD-1)/PD-L1 based regimen were included in this cohort. Participants received SAR444245 24 microgram per kilogram (mcg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line [2/3L] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
Cohort B1: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS >=1; SAR444245 24mcg/kg+Pembrolizumab as 1-3L Therapy. Participants with advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 & 3 gastro-esophageal junction adenocarcinoma (GEJ) and for whom standard of care (SOC) was not in best interest or where no SOC was established, non-high-level microsatellite instability (MSI-H) disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as first to [1-]3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months
Cohorts B1, B2 and B3: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 25 months
Cohort C: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 20 months
Cohorts D1 and D2: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Secondary Outcomes
Measure
Description
Time Frame
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the Investigator's opinion) or became serious during the TE period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
Participants with:
Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype.
Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by AASLD criteria in cirrhotic patients.
Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible.
Participants (all sub-studies) must have at least one measurable lesion.
Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator's discretion for the other cohorts.
Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 120 days (for Cohort A, B1, B2, B3, C, and D1) or 60 days (for Cohort D2) [corresponding to the time needed to eliminate any study intervention(s)].
and to refrain from donating or cryopreserving eggs for 120 days after discontinuing study treatment.
Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 3 days [corresponding to time needed to eliminate SAR444245] after the last dose of SAR444245.
Capable of giving signed informed consent.
Exclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
Poor organ function.
Active brain metastases or leptomeningeal disease.
History of allogenic or solid organ transplant.
Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration.
Comorbidity requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded).
Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP.
Severe or unstable cardiac condition within 6 months prior to starting study treatment.
Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years.
Participants with baseline SpO2 ≤92% (without oxygen therapy). - Participant has received prior IL2-based anticancer treatment.
Participants on sub-study02 cohort B1 and B2 or sub-study 04 - cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
Receipt of a live-virus or live attenuated-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Harris WP, Garcia-Alfonso P, Metges JP, Cubillo-Gracian A, Zaanan A, Carlos LL, Ronzoni M, Ponz-Sarvise M, Baakili A, Kefsi A, Andrieu L, Agrawal M, Wang W, Paehler T, Abbadessa G, Van Cutsem E. Evaluating pegenzileukin (SAR444245/THOR-707) in combination with pembrolizumab or cetuximab in advanced metastatic gastrointestinal cancer: the PEGATHOR phase 2 study. Invest New Drugs. 2026 Jun 22. doi: 10.1007/s10637-026-01622-2. Online ahead of print.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Note: Reason for not completed = Reason for permanent full intervention discontinuation.
Recruitment Details
This study was conducted at 29 centers (corresponds to number of site which screened at least one participant) in 9 countries. Out of 193 participants who were screened from 09 December 2021 to 26 October 2022, a total of 138 participants were enrolled in the study and were assigned to 1 of the 7 cohorts (Cohorts A, B1, B2, B3, C, D1 and D2) based on their disease type.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC), regardless of programmed cell death-ligand 1 (PD-L1) expression (any combined positive score [CPS]), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-programmed cell death-1 (PD-1)/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (mcg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line [2/3L] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
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
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 21, 2022
Jun 3, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Germany
Poland
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
Experimental
Cohort B2: GC/GEJ PD-1/PD-L1 naïve non-MSI-H CPS <1; SAR444245 24 mcg/kg+Pembrolizumab as 1-3L Therapy. Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Drug: THOR-707
Drug: Pembrolizumab
Cohort B3: GC/GEJ Post PD-1/PD-L1 non-MSI-H; SAR444245 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Experimental
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-fourth [4]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Drug: THOR-707
Drug: Pembrolizumab
Cohort C: HCC Post PD-1/PD-L1; SAR444245 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Experimental
Participants with advanced unresectable or metastatic hepatocellular carcinoma (HCC), regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least stable disease (SD) as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Drug: THOR-707
Drug: Pembrolizumab
Cohort D1: CRC non-MSI-H any RAS; SAR444245 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Experimental
Participants with advanced unresectable or metastatic colorectal cancer (CRC), regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received SAR444245 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-sixth [6]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received SAR444245 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/square meter (m^2) on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)
All Cohorts: Time to Response (TTR)
TTR was defined as the time from the date of first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
All Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed to the date of first documentation of objective PD before the initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
All Cohorts: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with clinical benefit (confirmed CR or PR as best overall response [BOR], or SD lasting at least 6 months), as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response recorded from the start of the study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
All Cohorts: Progression-Free Survival (PFS)
PFS was defined as the time from the date of first study treatment to the date of the first documentation of objective PD or death due to any cause, whichever occurred first, as per RECIST v 1.1. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
Maximum Concentration Observed (Cmax) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Cmax of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Last Concentration Observed Above the Lower Limit of Quantification (Clast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Clast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Time of the Last Concentration Observed Above the Lower Limit of Quantification (Tlast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of tlast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time Zero to Tlast (AUClast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of AUClast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of AUC of pegenzileukin. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Observed Accumulation Ratio (Rac) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Rac of pegenzileukin. Rac was calculated as AUC at Cycle 4 Day 1/AUC at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Rac,cmax of pegenzileukin. Rac,cmax was calculated as Cmax at Cycle 4 Day 1/Cmax at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
Cohort D2: Concentration Observed Just Before Intervention Administration During Repeated Dosing (Ctrough) of Cetuximab
Blood samples were collected at specified timepoints for the assessment of Ctrough of Cetuximab. The PK parameters were calculated using non-compartmental method.
Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)
Cohort D2: Concentration at End of Infusion (Ceoi) of Cetuximab
Blood samples were collected at specified timepoints for the assessment of Ceoi of Cetuximab. The PK parameters were calculated using non-compartmental method.
Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)
All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin
Blood samples were collected at specified timepoints to assess the presence of ADA against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)
Orlando
Florida
32804
United States
Seattle Cancer Care Alliance Site Number : 8400009
Seattle
Washington
98115
United States
Investigational Site Number : 0560002
Brussels
BE-1200
Belgium
Investigational Site Number : 0560003
Edegem
2650
Belgium
Investigational Site Number : 0560001
Leuven
3000
Belgium
Investigational Site Number : 1520001
Santiago
Reg Metropolitana de Santiago
8420383
Chile
Investigational Site Number : 1560002
Wuhan
430022
China
Investigational Site Number : 2500004
Bordeaux
33075
France
Investigational Site Number : 2500006
Brest
29200
France
Investigational Site Number : 2500002
Paris
75015
France
Investigational Site Number : 2500005
Poitiers
86021
France
Investigational Site Number : 2500001
Villejuif
94800
France
Investigational Site Number : 3800001
Rozzano
Lombardy
20089
Italy
Investigational Site Number : 3800003
Milan
20132
Italy
Investigational Site Number : 3800002
Milan
20133
Italy
Investigational Site Number : 5280001
Amsterdam
1081 HV
Netherlands
Investigational Site Number : 5280003
Rotterdam
3015 GD
Netherlands
Investigational Site Number : 4100002
Seoul
Seoul-teukbyeolsi
03080
South Korea
Investigational Site Number : 4100004
Seoul
Seoul-teukbyeolsi
03722
South Korea
Investigational Site Number : 4100001
Seoul
Seoul-teukbyeolsi
05505
South Korea
Investigational Site Number : 4100003
Seoul
Seoul-teukbyeolsi
06351
South Korea
Investigational Site Number : 7240002
Barcelona
Barcelona [Barcelona]
08035
Spain
Investigational Site Number : 7240006
Barcelona
Barcelona [Barcelona]
08036
Spain
Investigational Site Number : 7240005
Santander
Cantabria
39008
Spain
Investigational Site Number : 7240101
Madrid
Madrid, Comunidad de
28027
Spain
Investigational Site Number : 7240003
Madrid / Madrid
Madrid, Comunidad de
28007
Spain
Investigational Site Number : 7240004
Madrid / Madrid
Madrid, Comunidad de
28050
Spain
Investigational Site Number : 7240001
Pamplona
Navarre
31008
Spain
FG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 & 3 gastro-esophageal junction adenocarcinoma (GEJ) and for whom standard of care (SOC) was not in best interest or where no SOC was established, non-high-level microsatellite instability (MSI-H) disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as first to [1-]3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
FG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS <1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
FG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-fourth [4]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
FG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic hepatocellular carcinoma (HCC), regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least stable disease (SD) as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
FG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic colorectal cancer (CRC), regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-sixth [6]L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/square meter (m^2) on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
FG0005 subjects
FG00122 subjects
FG00219 subjects
FG00318 subjects
FG00420 subjects
FG00530 subjects
FG00624 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0005 subjects
FG00121 subjects
FG00219 subjects
FG00318 subjects
FG00420 subjects
FG00530 subjects
FG00624 subjects
Type
Comment
Reasons
Adverse event: Related to Coronavirus Disease 2019 (COVID-19)
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Adverse event: Not related to COVID-19
FG0000 subjects
FG0015 subjects
FG0023 subjects
FG0031 subjects
FG004
Progressive disease
FG0003 subjects
FG00113 subjects
FG00213 subjects
FG00317 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
The exposed population included all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
BG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
BG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
BG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
BG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
BG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG00122
BG00219
BG00318
BG00420
BG00530
BG00624
BG007138
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
BG00063.2± 4.4
BG00158.1± 10.3
BG00256.5± 13.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Cohort A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00020.0(1.0 to 65.7)
Primary
Cohorts B1, B2 and B3: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 25 months
ID
Title
Description
OG000
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Primary
Cohort C: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 20 months
ID
Title
Description
OG000
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Primary
Cohorts D1 and D2: Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months
ID
Title
Description
OG000
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the Investigator's opinion) or became serious during the TE period.
The exposed population included all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).
Posted
Count of Participants
Participants
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Secondary
All Cohorts: Time to Response (TTR)
TTR was defined as the time from the date of first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed.
Posted
Mean
Standard Deviation
months
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Secondary
All Cohorts: Duration of Response (DOR)
DOR was defined as the time from the date of first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed to the date of first documentation of objective PD before the initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed.
Posted
Median
90% Confidence Interval
months
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Secondary
All Cohorts: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with clinical benefit (confirmed CR or PR as best overall response [BOR], or SD lasting at least 6 months), as per RECIST v 1.1. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response recorded from the start of the study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Number
90% Confidence Interval
percentage of participants
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Secondary
All Cohorts: Progression-Free Survival (PFS)
PFS was defined as the time from the date of first study treatment to the date of the first documentation of objective PD or death due to any cause, whichever occurred first, as per RECIST v 1.1. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
The efficacy population included all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment.
Posted
Median
90% Confidence Interval
months
From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 8 months (Cohort A, D1 and D2), 25 months (Cohort B1, B2 and B3), 20 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Secondary
Maximum Concentration Observed (Cmax) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Cmax of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Last Concentration Observed Above the Lower Limit of Quantification (Clast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Clast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Time of the Last Concentration Observed Above the Lower Limit of Quantification (Tlast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of tlast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Median
Full Range
Hours (h)
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time Zero to Tlast (AUClast) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of AUClast of pegenzileukin. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of AUC of pegenzileukin. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Observed Accumulation Ratio (Rac) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Rac of pegenzileukin. Rac was calculated as AUC at Cycle 4 Day 1/AUC at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of Rac,cmax of pegenzileukin. Rac,cmax was calculated as Cmax at Cycle 4 Day 1/Cmax at Cycle 1 Day 1. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Same dose of pegenzileukin was administered to all participants in Cohorts A, B1, B2, B3, C, D1 and D2 of the study. Hence PK analysis was combined for all the cohorts. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Day 1 Cycle 1 and Day 1 Cycle 4 (each cycle is 21 days)
ID
Title
Description
OG000
All Cohorts: Pegenzileukin 24 mcg/kg
All participants received pegenzileukin 24 mcg/kg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG000
Secondary
Cohort D2: Concentration Observed Just Before Intervention Administration During Repeated Dosing (Ctrough) of Cetuximab
Blood samples were collected at specified timepoints for the assessment of Ctrough of Cetuximab. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
Secondary
Cohort D2: Concentration at End of Infusion (Ceoi) of Cetuximab
Blood samples were collected at specified timepoints for the assessment of Ceoi of Cetuximab. The PK parameters were calculated using non-compartmental method.
The PK population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Cycles 1, 2, 3, 4, 6 and 8 (each cycle is 21 days)
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
Secondary
All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin
Blood samples were collected at specified timepoints to assess the presence of ADA against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.
The ADA population included all participants from exposed population with at least one ADA result (positive, negative or inconclusive) after the first dose of study treatment.
Posted
Count of Participants
Participants
From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C)
ID
Title
Description
OG000
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Time Frame
AEs and SAEs were collected from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C). All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant, up to approximately 19 months.
Description
Analysis was performed on the exposed population.
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
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
1
5
2
5
5
5
EG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
16
22
17
22
20
22
EG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
15
19
13
19
18
19
EG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
12
18
9
18
17
18
EG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
6
20
7
20
19
20
EG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
18
24
11
24
24
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Covid-19
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected30 at risk
EG0061 events1 affected24 at risk
Cellulitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Device Related Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia Pneumococcal
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Sepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Septic Shock
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Metastases To Bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Cytokine Release Syndrome
Immune system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG00123 events3 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Hypophysitis
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Thyroiditis
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Abnormal Loss Of Weight
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0016 events5 affected22 at risk
EG00211 events10 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0025 events5 affected19 at risk
EG003
Mood Swings
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Brain Fog
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Headache
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events1 affected22 at risk
EG0023 events3 affected19 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Tremor
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dry Eye
Eye disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Eye Pain
Eye disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Eye Pruritus
Eye disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Embolism
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Flushing
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hot Flush
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hypertension
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hypotension
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Aphonia
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0023 events3 affected19 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected22 at risk
EG0023 events3 affected19 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Larynx Irritation
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Nasal Inflammation
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Respiratory Disorder
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Angular Cheilitis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Ascites
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0023 events2 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events4 affected22 at risk
EG0027 events5 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0003 events2 affected5 at risk
EG00112 events6 affected22 at risk
EG0029 events7 affected19 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events3 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Lip Ulceration
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Melaena
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0002 events1 affected5 at risk
EG0016 events4 affected22 at risk
EG00210 events9 affected19 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0014 events2 affected22 at risk
EG0025 events4 affected19 at risk
EG003
Biliary Obstruction
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Hepatic Pain
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Immune-Mediated Hepatitis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dermatitis Psoriasiform
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Hand Dermatitis
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events4 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5 at risk
EG0014 events3 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0023 events3 affected19 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0013 events2 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0024 events3 affected19 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Nocturia
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected19 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Congenital Rubella Syndrome
Congenital, familial and genetic disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Asthenia
General disorders
MedDra 27.0
Systematic Assessment
EG0004 events3 affected5 at risk
EG00118 events11 affected22 at risk
EG0025 events4 affected19 at risk
EG003
Chest Pain
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected19 at risk
EG003
Chills
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0023 events3 affected19 at risk
EG003
Fatigue
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events2 affected22 at risk
EG0026 events6 affected19 at risk
EG003
Influenza Like Illness
General disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG00118 events4 affected22 at risk
EG00227 events5 affected19 at risk
EG003
Localised Oedema
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Malaise
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0022 events1 affected19 at risk
EG003
Mucosal Inflammation
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Oedema Peripheral
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0026 events5 affected19 at risk
EG003
Pyrexia
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0015 events3 affected22 at risk
EG0026 events4 affected19 at risk
EG003
Thirst
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected19 at risk
EG003
Weight Decreased
Investigations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0024 events4 affected19 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0017 events4 affected22 at risk
EG0029 events8 affected19 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected19 at risk
EG003
The study was terminated due to early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Units
Counts
Participants
OG00022
OG00119
OG00218
Title
Denominators
Categories
Title
Measurements
OG00013.6(3.8 to 31.6)
OG0015.3(0.3 to 22.6)
OG00211.1(2.0 to 31.0)
Counts
Participants
OG00020
Title
Denominators
Categories
Title
Measurements
OG0005.0(0.3 to 21.6)
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG00030
OG00124
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 9.5)
OG0018.3(1.5 to 24.0)
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG0005
OG00122
OG00219
OG00318
OG00420
OG00530
OG00624
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0005
OG00122
OG00219
OG00318
OG00419
OG00530
OG00624
TESAEs
Title
Measurements
OG0002
OG00117
OG00213
OG003
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG0001
OG0013
OG0021
OG0032
OG0041
OG0050
OG0062
Title
Denominators
Categories
Title
Measurements
OG0001.9± NANA indicates that the standard deviation (SD) was not estimable for 1 participant.
OG0012.1± 0.2
OG0024.2± NANA indicates that the SD was not estimable for 1 participant.
OG0033.0± 1.3
OG0046.0± NANA indicates that the SD was not estimable for 1 participant.
OG0062.0± 0.1
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG0001
OG0013
OG0021
OG0032
OG0041
OG0050
OG0062
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates that the median, upper and lower limit of 90% confidence interval (CI) were not estimable due to insufficient number of participants with events.
OG00113.1(NA to NA)NA indicates that the upper and lower limit of 90% CI were not estimable, as there were insufficient numbers of participants with 2/3 participants censored prior to any event.
OG002NA(NA to NA)NA indicates that the median, upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0038.8(8.6 to NA)NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
OG004NA(NA to NA)NA indicates that the median, upper and lower limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0064.1(4.1 to NA)NA indicates that the upper limit of 90% CI was not estimable due to insufficient number of participants with events.
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG0005
OG00122
OG00219
OG00318
OG00420
OG00530
OG00624
Title
Denominators
Categories
Title
Measurements
OG00040.0(7.6 to 81.1)
OG00122.7(9.4 to 42.0)
OG00210.5(1.9 to 29.6)
OG00311.1(2.0 to 31.0)
OG00410.0(1.8 to 28.3)
OG0056.7(1.2 to 19.5)
OG00612.5(3.5 to 29.2)
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.
Units
Counts
Participants
OG0005
OG00122
OG00219
OG00318
OG00420
OG00530
OG00624
Title
Denominators
Categories
Title
Measurements
OG000NA(2.2 to NA)NA indicates that the median and upper limit of 90% CI were not estimable due to insufficient number of participants with events.
OG0011.9(1.2 to 2.9)
OG0022.0(1.4 to 3.5)
OG0032.1(1.8 to 2.2)
OG0042.1(1.9 to 2.2)
OG0052.0(1.9 to 2.1)
OG0062.1(2.0 to 4.1)
35
Title
Denominators
Categories
Day 1 Cycle 1
ParticipantsOG00035
Title
Measurements
OG000417± 109
Day 1 Cycle 4
ParticipantsOG00012
Title
Measurements
OG000369± 118
35
Title
Denominators
Categories
Day 1 Cycle 1
ParticipantsOG00035
Title
Measurements
OG00017.6± 13.4
Day 1 Cycle 4
ParticipantsOG0009
Title
Measurements
OG00013.0± 6.11
35
Title
Denominators
Categories
Day 1 Cycle 1
ParticipantsOG00035
Title
Measurements
OG00069.45(43.00 to 76.77)
Day 1 Cycle 4
ParticipantsOG0009
Title
Measurements
OG00068.82(46.28 to 72.58)
35
Title
Denominators
Categories
Day 1 Cycle 1
ParticipantsOG00035
Title
Measurements
OG0008940± 1930
Day 1 Cycle 4
ParticipantsOG0009
Title
Measurements
OG0007100± 2330
34
Title
Denominators
Categories
Day 1 Cycle 1
ParticipantsOG00034
Title
Measurements
OG0009270± 1990
Day 1 Cycle 4
ParticipantsOG0009
Title
Measurements
OG0007330± 2340
9
Title
Denominators
Categories
Title
Measurements
OG0000.772± 0.150
12
Title
Denominators
Categories
Title
Measurements
OG0000.887± 0.173
OG00019
Title
Denominators
Categories
Cycle 1
ParticipantsOG00018
Title
Measurements
OG0000.0± 0.0
Cycle 2
ParticipantsOG00019
Title
Measurements
OG00061689.5± 29031.6
Cycle 3
ParticipantsOG00014
Title
Measurements
OG00061647.1± 41623.9
Cycle 4
ParticipantsOG00010
Title
Measurements
OG00088670.0± 53487.3
Cycle 6
ParticipantsOG0009
Title
Measurements
OG00084377.8± 39150.0
Cycle 8
ParticipantsOG0004
Title
Measurements
OG000118375.0± 51770.9
OG00018
Title
Denominators
Categories
Cycle 1
ParticipantsOG00017
Title
Measurements
OG000245352.9± 57442.3
Cycle 2
ParticipantsOG00018
Title
Measurements
OG000209111.1± 52687.6
Cycle 3
ParticipantsOG00014
Title
Measurements
OG000214857.1± 69955.9
Cycle 4
ParticipantsOG00010
Title
Measurements
OG000236700.0± 63756.6
Cycle 6
ParticipantsOG0009
Title
Measurements
OG000233777.8± 53473.8
Cycle 8
ParticipantsOG0004
Title
Measurements
OG000248500.0± 59991.7
OG001
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS >=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG002
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS <1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35
OG003
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy
Participants with advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG004
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy
Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
OG005
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD.