PRESS RELEASE
For Immediate Release
Faeth Reports Positive Preliminary Phase 2 Topline Results from the PIK-201 Trial Evaluating PIKTOR in Combination with Paclitaxel in Patients with Advanced Endometrial Cancer
AUSTIN, Texas–(BUSINESS WIRE) — November 9, 2026– Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced topline clinical data from its Phase 2 trial (FTH-PIK-201; NCT06463028; GOG-3111) of PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib, given with paclitaxel to patients with advanced endometrioid endometrial cancer and a PI3K/AKT/mTOR (PAM) pathway mutation who had received at least one prior line of therapy. The trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F).
The Phase 2 trial is ongoing, and the topline data include 42 patients with endometrioid endometrial cancer who had a median of 2 prior lines of therapy (range 1-4 lines). As of the October 30, 2026 efficacy data cut, confirmed objective responses were observed in 12 of the 36 efficacy-evaluable patients, for a confirmed objective response rate (ORR) of 33%. One additional patient had a partial response that could not be confirmed because the patient discontinued the study before a confirmatory scan, for an unconfirmed ORR of 36% (13 of 36). Among patients with a PIK3CA mutation, the confirmed ORR was 44% (7 of 16). In the 42 treated patients, the preliminary Kaplan-Meier estimated median PFS was 7.4 months (95% CI 5.3-NR), and the 6-month progression-free survival (PFS) rate was 62% (95% CI 43%-75%); 16 patients remained on treatment at the data cut.
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