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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

FTH
  • Faeth Therapeutics announced Phase 2 topline data for PIKTOR (serabelisib & sapanisertib) combined with paclitaxel in patients with advanced endometrioid endometrial cancer.
  • Confirmed objective response rate (ORR) was 33% (12 of 36 efficacy-evaluable patients), with an unconfirmed ORR of 36% (13 of 36).
  • Among patients with a PIK3CA mutation, the confirmed ORR was 44% (7 of 16).
  • Disease control rate (DCR) was 83% (30 of 36 patients).
  • Preliminary median progression-free survival (mPFS) was 7.4 months, with a 6-month PFS rate of 62%.
  • The combination was generally well tolerated, with a treatment-related hyperglycemia rate of 12% (2% Grade 3) and stomatitis rate of 21% (2% Grade 3).
  • Discontinuation due to treatment-related adverse events occurred in 5% of patients.
  • Data support advancing PIKTOR development into a Phase 3 registrational trial.
  • The trial included 42 treated patients, 48% of whom had diabetes or pre-diabetes, with a median of 2 prior lines of therapy.
  • Faeth will host a webcast on November 9, 2026, at 8 a.m. ET to discuss the findings.