Endpoints
death
DISEASE PROGRESSION, DISEASE
The primary endpoint was PFS, defined as the time from the initiation of study treatment to the first disease progression per RECIST 1.1 or any-cause death, whichever came first.Secondary endpoints included objective response rate (ORR; defined as the proportion of patients with the best response of complete response [CR] or partial response [PR] per RECIST 1.1), duration of response (defined as the time from the first CR or PR to disease progression per RECIST 1.1 in patients with confirmed objective response), disease control rate (DCR; defined as the proportion of patients with the best response of CR, PR, or stable disease per RECIST 1.1), overall survival (OS; defined as the time from the initiation of study treatment to any-cause death), and safety.