FDA Grants Accelerated Approval To Verastem's Combination Drug For Ovarian Cancer

The Food and Drug Administration on Thursday granted accelerated approval to Verastem Inc.’s VSTM Avmapki Fakzynja Co-pack, a combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

Efficacy was evaluated in RAMP-201 (NCT04625270), an open-label, multicenter trial that included 57 adult patients with measurable KRAS-mutated recurrent LGSOC.

Also Read: Why Is Cancer-Focused Verastem Oncology Stock Trading Higher On Tuesday?

Patients received avutometinib 3.2 mg orally twice weekly (Day 1 and Day 4) and defactinib 200 mg orally twice daily, both taken for the first 3 weeks of each 4-week cycle until disease progression or unacceptable toxicity.

The major efficacy outcome measure was overall response rate (ORR). An additional efficacy outcome measure was duration of response (DOR).

The confirmed ORR was 44%, and the DOR range was 3.3 to 31.1 months.

The recommended avutometinib dose is 3.2 mg (four 0.8 mg capsules) taken orally twice weekly (Day 1 and Day 4) for the first 3 weeks of each 4-week cycle until disease progression or unacceptable toxicity.

The recommended defactinib dose is 200 mg (one tablet) taken orally twice daily for the first 3 weeks of each 4-week cycle until disease progression or unacceptable toxicity.

In April, Verastem Oncology announced a private placement of approximately $24 million of shares at $7.00 per share and, in lieu of common stock, $51 million of pre-funded warrants at $6.9999 per pre-funded warrant.

Verastem expects to receive gross proceeds from the offering of approximately $75 million.

The company said it would use the proceeds to fund the potential launch of avutometinib and defactinib, as well as continued clinical research and development of product candidates, including VS-7375, working capital, and other general corporate purposes.

In April, the FDA cleared Verastem Oncology’s Investigational New Drug application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation.

The company expects to initiate a Phase 1/2a study in mid-2025 and plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancer.

Price Action: VSTM stock was trading 3.14% higher at $6.89 at the last check on Thursday.

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