Outcomes
SAEs, tumor, death, Cancer
DISEASE PROGRESSION, TUMOR, ADVERSE EVENT, CANCER
The primary endpoint was confirmed ORR, as measured by BICR per RECIST v1.1 criteria, defined as the proportion of patients with a best overall response of either CR or PR. ORR was assessed after all patients had completed the third on-study tumor assessment (after ~6 months) or had discontinued from the study, whichever occurred first. Patients with unknown or missing responses were counted as ‘not done’ but were included in the denominator when calculating percentage of responses.Secondary efficacy endpoints included PFS (defined as the time from date of randomization to date of disease progression [as per RECIST v1.1 by investigator assessment] or any-cause death, whichever occurred first) and OS (defined as the time from date of randomization to the date of any-cause death). Prespecified exploratory analyses of ORR and PFS by PD-L1 subgroups TPS < 1%, TPS 1–49%, TPS ≥ 50%, and TPS ≥ 1% were also performed. A prespecified subgroup analysis of ORR by sex was conducted and was previously reportedSafety assessments included vital signs, clinical laboratory parameters, and incidence of TEAEs, SAEs, TEAEs leading to death, and AEs leading to discontinuation. AEs were coded using standard Medical Dictionary for Regulatory Activities (MedDRA) terminology and graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.Two data-cuts have been used for the data analyses in this manuscript. ORR, PFS and safety analyses have been reported per August 4, 2022, data cut-off. Updated analyses of ORR, DOR, OS and safety have been reported per July 7, 2023, data cut-off.