Outcomes
death, SD, TTP
BRAIN METASTASES, DISEASE PROGRESSION, DISEASE, TTP
The primary endpoint was the independent review committee (IRC)-assessed ORR. Secondary endpoints included investigator-assessed ORR, disease control rate (DCR), duration of response (DoR), PFS, time to progression (TTP), and intracranial ORR (iORR), overall survival (OS), safety, and PK parameter (minimum concentration at steady-state [CORR was defined as the proportion of patients with complete response (CR) or partial response (PR). DCR was defined as the proportion of patients with CR, PR, or stable disease (SD). DoR was defined as the time from the date of the first CR or PR to the first time of disease progression or death from any cause, whichever occurred first. PFS was defined as the time from enrollment to the first time of disease progression or death from any cause, whichever occurred first, and TTP was defined as the time from enrollment to disease progression. iORR was defined as the proportion of patients with investigator-assessed intracranial CR or PR according to RANO brain metastases criteria. OS was defined as the time from enrollment to death from any cause.The efficacy endpoints were evaluated in the full analysis set (FAS). The per-protocol set (PPS) and response evaluable set (RES) were used for sensitivity analyses. The FAS included all patients who received at least one dose of iruplinalkib. The PPS included patients in the FAS who complied with the protocol. The RES included patients in the FAS with measurable lesions by IRC at baseline. The safety analysis was conducted in the safety set (SS) which included patients who received at least one dose of iruplinalkib and one post baseline safety evaluation. PK were analyzed in patients who received at least one dose of iruplinalkib and provided at least one blood sample for the measurement of iruplinalkib concentrations.