Endpoints
tumor, Cancer
ADVERSE EVENTS, ADVERSE EVENT, TUMOR, CANCER
The primary endpoint of this study was progression‐free survival (PFS) by investigator assessment per RECIST v1.1. Following the screening tumor assessment, tumor imaging assessments were performed every 8 weeks (±7 days) after Day 1 (the first day of study drug administration). Secondary endpoints included OS, time to second subsequent treatment (TSST), objective response rate (ORR), duration of response (DoR), and time to response (TTR). ORR was defined as the proportion of patients with a best overall response of CR or PR per RECIST v1.1 by investigator assessment. Safety was evaluated through the incidence and severity of treatment‐emergent adverse events (TEAEs), including treatment‐related adverse events (TRAEs). TEAEs were graded according to National Cancer Institute‐Common Terminology Criteria for Adverse Events v4.03 or higher.