Faeth’s PIKTOR plus paclitaxel combo gains FDA fast track status

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.

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.

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