Endpoints and assessments
Tumors, death, SD
TUMORS, DISEASE PROGRESSION, DISEASE
The primary endpoint was ORR in full analysis set (FAS) evaluated by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [FAS referred to all patients enrolled who received at least one dose of rezivertinib. SS included all patients who received at least one dose of rezivertinib and had safety data available. ORR was defined as the proportion of patients with confirmed complete response (CR) or partial response (PR). DCR was defined as the proportion of patients who had confirmed CR, PR, or stable disease (SD). DoR was defined as the time from the first CR or PR to disease progression or death which applied only to patients with confirmed CR or PR. PFS was defined as the time from the first dose of rezivertinib until the earliest date of documented disease progression or death due to any cause. OS was defined as the time from the date of the first dose of rezivertinib until death due to any cause. CNS-ORR was defined as the proportion of confirmed CR or PR in brain metastatic lesions, as evaluated by BICR according to the RANO-BM criteria. CNS-DCR was defined as the proportion of confirmed CR, PR, or SD in brain metastatic lesions evaluated by BICR according to the RANO-BM criteria.