Antitumor efficacy
tumors
DISEASE, TUMORS
The primary efficacy endpoint was the ORR, defined as the number of patients with the best objective response of complete response (CR) or partial response (PR), divided by the total number of patients analyzed in the same treatment group. Response was determined by investigator assessment and based on RECIST v1.1. Additional efficacy endpoints included disease control rate (sum of CR, PR, and stable disease rates), PFS, OS, and percentage change in the size of the target lesion. Starting from Day 1 of Cycle 1, tumors were assessed every 6 weeks for the first 24 weeks (i.e., first 8 cycles), then every 12 weeks thereafter (i.e., every 4 cycles).