Faeth Therapeutics Reports Positive Phase 2 Results for PIKTOR in Advanced Endometrial Cancer

Faeth Therapeutics announced preliminary Phase 2 data indicating a 33% confirmed objective response rate for its PIKTOR candidate when paired with paclitaxel to treat advanced endometrioid endometrial cancer, according to OncoDaily.

$FTH Clinical Data Presentation: On November 9, 2026, Faeth Therapeutics, Inc. released a presentation discussing the topline clinical data from its Phase 2 trial evaluating PIKTOR for advanced endometrial cancer. (Visit stockinsights dot ai for full context)

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The ongoing, open-label, single-arm trial evaluates PIKTOR—an oral combination of serabelisib and sapanisertib—alongside paclitaxel in patients whose tumors harbor a PI3K/AKT/mTOR pathway mutation. Patients had received a median of two prior lines of therapy, and 98% had previously undergone immunotherapy.

At the October 30, 2026 efficacy cutoff, confirmed objective responses were observed in 12 of 36 efficacy-evaluable patients. Including one patient who achieved a partial response but left the trial prior to a confirmatory scan resulted in an ORR of 36% (13 of 36). The disease control rate reached 83%, and preliminary median progression-free survival was estimated at 7.4 months.

Clinical Need and Next Steps

The clinical requirements driving this research were outlined by David Starks, a Gynecologic Oncologist at Avera Cancer Institute in Sioux Falls, South Dakota, who serves as a principal investigator for both the PIK-201 trial and the GOG Foundation.

“We need more treatment options for patients whose advanced endometrial cancer has progressed after platinum chemotherapy and immunotherapy,” Starks told OncoDaily.”

Anand Parikh, Co-Founder and Chief Executive Officer of Faeth, outlined the company’s next move, noting that the preliminary 7.4-month median progression-free survival compares favorably to the 3-4 months typical for salvage chemotherapy alone.

“We now plan to advance toward a Phase 3 trial, subject to regulatory alignment, with the goal of getting PIKTOR into the hands of patients as expeditiously as possible,” Parikh told Investing.com via Yahoo Finance.”

Safety Profile

As of the safety cutoff on October 23, 2026, 64% of participants had encountered a treatment-related adverse event of grade 3 or higher. Neutropenia was the most frequent severe event, occurring in 26% of patients at grade 3 or higher. Treatment-related hyperglycemia occurred in 12% of patients, and stomatitis in 21%. Two patients discontinued treatment due to treatment-related adverse events, and no treatment-related deaths were reported.

Faeth Therapeutics Reports Positive Phase 2 Results for PIKTOR in Advanced Endometrial Cancer — Photo: finance.yahoo.com

The single-arm design of the Phase 2 PIK-201 trial leaves the incremental benefit of adding serabelisib and sapanisertib to paclitaxel unresolved, and a controlled trial would be needed to assess comparative efficacy.