Efficacy assessments
death, BOR, SD, Tumor
DISEASE PROGRESSION, TUMOR, DISEASE, BEST, DISEASE
Tumor response was assessed according to RECIST v1.1 after every cycle (approximately 4 weeks) for the first 3 cycles and then every 8 weeks (± 7 days) thereafter. Assessments included computed tomography (CT) scans with oral or intravenous contrast (unless contraindicated) of the chest, abdomen, and pelvis or magnetic resonance imaging scans if CT contrast was contraindicated. Other assessment methods were used if clinically indicated. The assessment method used for each patient at baseline was the same throughout the study.Best overall response (BOR) was determined using all time point responses (TPRs) up until the last evaluable TPR prior to or on the date of (i) radiological disease progression as defined by RECIST v1.1 or death; or (ii) loss to follow-up or withdrawal of consent; or (iii) receipt of subsequent anti-cancer medications, whichever was earlier. Investigator-assessed objective response rate (ORR) was defined as the proportion of patients with BOR of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. The interval for confirmation of CR and PR was at least 4 weeks. Disease control rate (DCR) was defined as the proportion of patients with a BOR of confirmed CR, confirmed PR, or stable disease (SD) lasting for at least 7 weeks. Duration of response (DoR) was calculated as the time (in months) from the date of first objective response (CR or PR confirmed after ≥ 4 weeks) until the date of the documented progression or death, whichever came first. PFS was defined as the time (months) from the date of first administration of study drug until the date of radiological disease progression or death due to any cause, whichever came first.