Faeth Therapeutics has earned FDA Fast Track designation for PIKTOR — an all-oral combination of sapanisertib and serabelisib administered with paclitaxel — for advanced or recurrent endometrial cancer in patients with PI3K/AKT/mTOR pathway alterations who progressed after platinum chemotherapy and an immune checkpoint inhibitor. The combination is being tested in Phase II Study FTH-PIK-201, with top-line results expected by year-end. PIKTOR is also in a Phase Ib/II breast cancer trial (FTH-PIK-101), which dosed its first patient in April and plans interim data in 2027.
Faeth’s Oral PIKTOR + Paclitaxel Wins FDA Fast Track for Advanced Endometrial Cancer
Faeth Therapeutics is conducting a Phase II trial
Faeth Therapeutics has secured Fast Track designation from the U.S. Food and Drug Administration for PIKTOR — the investigational all-oral combination of sapanisertib and serabelisib — when given with paclitaxel to treat advanced or recurrent endometrial cancer.
Who Is Eligible
The designation specifically targets patients whose tumors harbor alterations in the PI3K/AKT/mTOR signaling pathway and who have experienced disease progression after prior platinum-based chemotherapy and treatment with an immune checkpoint inhibitor.
Clinical Development And Timeline
Faeth is evaluating this regimen in a Phase II study, FTH-PIK-201, as a second-line therapy for advanced endometrial cancer. The company expects to report top-line results from FTH-PIK-201 by the end of this year.
PIKTOR is also being tested in a Phase Ib/II study for hormone receptor–positive, HER2-negative (HR+/HER2-) advanced breast cancer (Study FTH-PIK-101). The first patient was dosed in April, and Faeth anticipates interim results from that trial in 2027.
About PIKTOR
PIKTOR combines sapanisertib and serabelisib in an all-oral regimen designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway — a signaling axis that published studies report is altered in up to half of solid tumors. Faeth positions PIKTOR as a "multi-node" approach intended to overcome resistance mechanisms and potentially resensitize tumors to chemotherapy.
Anand Parikh, CEO of Faeth Therapeutics: "Fast Track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor. We believe PIKTOR's multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitize patients to chemotherapy."
What Fast Track Means
Fast Track is intended to expedite the development and review of therapies for serious conditions with unmet medical need. The designation can enable more frequent FDA interactions, rolling submission of data, and potentially faster access to priority review if later criteria are met.
Faeth continues to advance PIKTOR as its lead development program within a broader focus on multi-node cancer therapies.
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