Faeth Reports Preliminary Phase 2 PIKTOR Results: 33% Confirmed Response Rate
Faeth Therapeutics reported preliminary topline results from its Phase 2 PIK-201 trial of PIKTOR with paclitaxel in 42 treated patients with advanced endometrial cancer, using an October 30, 2026 efficacy data cut. The confirmed objective response rate was 33% (12 of 36 efficacy-evaluable patients) and preliminary median progression-free survival was 7.4 months, and the company said the data support advancing to a Phase 3 trial. The results are preliminary, the trial is single-arm, and 64% of patients had a grade 3 or higher treatment-related adverse event.
Key points
- Confirmed ORR of 33% (12 of 36); unconfirmed ORR of 36% (13 of 36); 44% confirmed ORR (7 of 16) in patients with a PIK3CA mutation
- Preliminary median PFS of 7.4 months (95% CI 5.3 to NR); 6-month PFS rate of 62%
- 64% of patients had a grade 3 or higher treatment-related adverse event; 2 patients (5%) discontinued due to treatment-related adverse events; no treatment-related deaths
- Company webcast held November 9, 2026 at 8:00 a.m. ET
The filing
Written by AI on Nov 9, 2026, 7:32 AM ET, from this filing only.
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