Table 1.
Sub-study | Pts enrolled N | Pts evaluable for response N | PR (%) | SD (%) | PD (%) | PFS6 rate (%) | Pts evaluable for toxicity N | AEs (%) | Grade 3/4 AEs (%) | Comments |
---|---|---|---|---|---|---|---|---|---|---|
Arm W: Pts with FGFR1–3 mutation or translocation receive FGFR Inhibitor AZD4547 [12] | 52 | 41 | 5 | 51 | 44 | 17 | 49 | 80 | 49 | Failed to meet its primary endpoint |
Arm Q: Pts with HER2 amplification receive trastuzumab emtansine [13] | N/R | 37 | 8.1 | 43 | N/R | 24.8 | N/R | N/R | N/R | Failed to meet its primary endpoint |
Arm I: Pts with PIK3CA mutation without RAS mutation or PTEN loss receive taselisib [14] | 65 | N/R | 0 | N/R | N/R | 27 | N/R | N/R | N/R | Failed to meet its primary endpoint; Co-occurring mutations were detected in 67% of tumors; 11% of pts. discontinued taselisib because of toxicity |
AEs Adverse events, N/R Not reported, OR Objective response, PD Progressive disease, PFS6 Progression-free survival at 6 months of treatment, PR Partial response, Pts Patients, SD Stable disease