Statistical analysis
The full analysis set (FAS), defined as patients who received at least one dose of the investigational product, was the primary analysis set for all efficacy and safety analyses. The per-protocol set (PPS) was a subset of the FAS, consisting of all patients without major protocol deviation. The PPS served as support for the FAS. The safety set (SS) was defined as a collection of patients who received at least one dose of the investigational treatment.Statistical analyses were performed based on the FAS, PPS, and SS using SAS version 9.2 (or later) software (SAS Institute, Cary, NC). There was no hypothesis testing, as this was an open-label, single-arm study. Confidence intervals (CIs) for ORR were estimated using the Exact (Clopper–Pearson) method. OS, PFS, and DOR were estimated using the Kaplan–Meier method. DOR analysis included patients who had achieved objective response. Patient flow through the trial, and demographic and baseline characteristics, were summarized by descriptive statistics.