Statistical Analysis
Patient demographics and baseline characteristics were described using frequencies and percentages (%) for categorical variables and medians and interquartile ranges for continuous variables. Safety and clinical activity (ORR, DCR, and radiological PFS) were analyzed in all patients. Estimates of the percentage of patients with objective response and the exact 2-sided 95% CI were computed according to the exact Clopper-Pearson method. Response duration and PFS were estimated using the Kaplan-Meier method.