Efficacy
PD, tumor, tumors, mutated tumors
DISEASE, TUMORS, TUMOR
Five of the 18 patients had PR (4 and 1 in the 6 mg and 8 mg QD groups, respectively), with an ORR of 27.8% (95% CI, 9.7%–53.5%), a DCR of 55.6% (95% CI, 30.8%–78.5%) and a median PFS of 3.9 (95% CI, 2.0‐NA) months. In the 6 mg QD group, ORR and DCR were 66.7% (95% CI, 22.3%–95.7%) and 83.3% (95% CI, 35.9%–99.6%), respectively, and median PFS was not reached at the time of data cut‐off (Table Efficacy data.Abbreviations: CI, confidence interval; CR, complete response; DCR, disease control rate; NA, not available; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; PFS, progression‐free survival; SD, stable disease.Waterfall plot for tumor response in individual patients. CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; Y, yes; N, no.For the 9 patients with PIK3CA mutated tumors confirmed by the central laboratory and/or previous medical records, ORR and DCR were 44.4% (95% CI, 13.7%–78.8%) and 77.8% (95% CI, 40.0%–97.2%), respectively. The median PFS was 11.1 (95% CI, 2.1‐NA) months (Table For the six patients with PIK3CA mutated tumors confirmed by the central laboratory, ORR, DCR, and DoR were 50.0% (95% CI, 11.8%–88.2%), 100.0% (95% CI, 54.1%–100.0%), and NA (95% CI, 9.1‐NA) months, respectively (Table For the 10 patients with PIK3CA wild‐type tumors confirmed by the central laboratory, the ORR and DCR were 10.0% (95% CI, 0.3%–44.5%) and 20.0% (95% CI, 2.5%–55.6%), respectively (Table Of the five patients with confirmed PR, three had PR at the first follow‐up visit for tumor assessment on Day 1 of Cycle 3 (C3D1), and the other two had PR at the third follow‐up visit on C7D1. For example, one PIK3CA‐positive patient in the 6 mg QD group had PR on C3D1, and the target lesion continued to shrink in subsequent follow‐up visits, maintaining PR as of the data cut‐off date (C15D1). Another PIK3CA‐positive patient in the 6 mg QD group had target lesion shrinkage on C3D1 and had PR on C7D1, maintaining PR as of the data cut‐off date (C13D1) (Figure 