Assessments and outcomes
Tumour, tumour, Cancer
ADVERSE EVENT, TUMOUR, ADVERSE EVENT, TUMOUR, INFUSION REACTION, CPS, CANCER
Tumour responses were assessed using Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST v1.1), by blinded independent central review (BICR) every 6 weeks. Adverse events were assessed throughout the study and at 30 days after treatment discontinuation (90 days for serious AEs and immune-mediated AEs and infusion reactions) and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). PD-L1 expression was centrally assessed during screening using PD-L1 IHC 22C3 pharmDx (Agilent) and was scored using CPS (the number of PD-L1–staining cells [tumour cells, lymphocytes, macrophages] divided by the total number of viable tumour cells, multiplied by 100).The current analysis evaluated OS, progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR) based on BICR assessment per RECIST v1.1 in patients with PD-L1 CPS ≥1 (intention-to-treat population) and in patients with PD-L1 CPS ≥10. Safety and tolerability were also evaluated.