Fig. 4

Clonal multiple PIK3CAmut status correlates with higher ORR and longer PFS. A – C Bar plots of overall objective response rate (ORR) for SANDPIPER study participants show that ORR trends higher or is significantly higher in those whose baseline ctDNA harbored clonal vs subclonal multiple PIK3CAmut. A Study participants who received either study treatment regimen: clonal [14 responses of 47 participants = 30% ORR (95% CI, 17–45)] vs subclonal [1 response of 19 participants = 5.3% ORR (95% CI, 0.13–26)]; p = 0.021. B Study participants who received placebo + fulvestrant: clonal [2 responses of 18 participants = 11% ORR (95% CI, 1.4–35)] vs subclonal [0 responses of 5 participants = 0.00% ORR (95% CI, 0.0–52)]; p = 1.0. C Study participants who received taselisib + fulvestrant: clonal [12 responses of 29 participants = 41% ORR (95% CI, 243.5–61)] vs subclonal [1 response of 14 participants = 7.1% ORR (95% CI, 0.18–34)]; p = 0.033. D Shown via Kaplan–Meier curves, median progression-free survival (PFS) was longer for those whose corresponding baseline ctDNA harbored clonal multiple PIK3CAmut vs subclonal multiple PIK3CAmut and were treated with either placebo + fulvestrant [median PFS (mPFS) = 3.9 vs 2.0 months, respectively; Hazard Ratio (HR) = 0.19 (95% CI, 0.051–0.73), p = 0.025] or with taselisib + fulvestrant [mPFS = 7.6 vs 5.1 months, respectively; HR = 0.37 (95% CI, 0.16–0.87), p = 0.027]. See Methods on details for calculations and statistics of ORR and PFS. mut, mutation(s); n, number of study participants or samples in the indicated subgroup