Faeth Therapeutics has received the US Food and Drug Administration’s (FDA) fast track designation for the sapanisertib and serabelisib (PIKTOR) with paclitaxel combination to treat advanced or recurrent endometrial cancer.
The designation applies specifically to patients whose tumours contain a phosphatidylinositol 3-kinase / protein kinase B / mechanistic target of rapamycin (PI3K/AKT/mTOR) pathway alteration.
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It also applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor.
Faeth Therapeutics is currently conducting a Phase II trial of this treatment approach, known as Study FTH-PIK-201, in second-line advanced endometrial cancer.
The company anticipates releasing top line results from this trial by the end of this year.
Faeth Therapeutics CEO Anand Parikh said: “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 resensitise patients to chemotherapy.”
PIKTOR is described as an investigational, all-oral combination therapy and is designed to inhibit several nodes of the PI3K/AKT/mTOR pathway, which, according to published literature, is altered in up to half of all solid tumours.
In addition to the endometrial cancer trial, PIKTOR is being tested in a Phase Ib/II study for hormone receptor positive / human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer, referred to as Study FTH-PIK-101.
The first patient in this study was dosed in April, with interim results expected in 2027.
Faeth Therapeutics focuses on multi-node therapies for cancer, with PIKTOR as its leading development programme.
