(A) Waterfall plot of the best percent change from baseline in the sum of the diameters of target lesions. Eighty-eight (82.2%) patients had a decrease in tumor size from baseline as assessed by the BIRC. (B) Swimmer plot of patients' responses from the start of treatment to PD assessed by the BIRC, death, or withdrawal. Fifty-four patients (50.5%) were responders whose target lesion decreased by not <30%, and one patient (0.9%) and 53 patients (49.5%) were assessed as confirmed CR and PR, respectively. The best response of 34 patients (31.8%) was SD, and 19 patients had PD. (C) Forest plot of the ORRs in key subgroups. The subgroups were based on the baseline disease characteristics. The confirmed ORR was evaluated in the key prespecified subgroups per the BIRC. BIRC, blinded independent review committee; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.