Pre-specified outcomes
Cancer
ADVERSE EVENT, ADVERSE EVENT, CANCER
The primary endpoints were OS and progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST version 1.1 in patients with tumor-cell PD-L1 expression ≥ 1%. Secondary endpoints comprised OS and PFS (BICR) in all randomized patients, and objective response rate (ORR) per BICR in patients with tumor-cell PD-L1 expression ≥ 1% and all randomized patients. Key exploratory endpoints included investigator-assessed PFS, subgroup analyses for OS based on demographics and clinical factors for all patients, duration of response (BICR), and safety. Efficacy endpoints were assessed for the global intent-to-treat population. Adverse events (AEs) were assessed in all the patients who had received ≥ 1 dose of the assigned treatment, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0.