Verastem Oncology, a company dedicated to developing cancer treatments, has released promising data from its Phase 2 RAMP 201 clinical trial. This trial examines the effectiveness of combining avutometinib (a RAF/MEK clamp) and defactinib (a FAK inhibitor) in patients with recurrent low-grade serous ovarian cancer (LGSOC).

The trial demonstrated a 31% overall response rate in patients with measurable disease, with a median duration of response of 31.1 months. Notably, patients with the KRAS mutant gene exhibited a higher response rate of 44%, while those with the KRAS wild-type gene had a 17% response rate. Median progression-free survival for all patients was 12.9 months, increasing to 22 months for those with the KRAS mutant gene.

The combination treatment was generally well-tolerated, with the most frequent side effects being nausea, diarrhea, and elevated blood creatine phosphokinase levels. Importantly, no new safety concerns were identified.

Based on these positive results, Verastem Oncology plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October 2024 for the treatment of adult patients with recurrent KRAS mutant LGSOC. The company is seeking Accelerated Approval and Priority Review from the FDA. While the FDA did not recommend pursuing Accelerated Approval for the KRAS wild-type indication, Verastem is committed to exploring this pathway further, leveraging data from the ongoing RAMP 301 Phase 3 trial.

Verastem believes that the combination of avutometinib and defactinib can potentially become the preferred treatment for all LGSOC patients, regardless of their KRAS mutation status. This treatment could address the unmet needs of individuals with recurrent LGSOC, offering new hope and potentially extending survival for this patient population.

Source link: http://www.businesswire.com/news/home/20241016127866/en/Verastem-Oncology-Presents-Positive-Updated-RAMP-201-Data-for-Avutometinib-and-Defactinib-Combination-in-Recurrent-Low-Grade-Serous-Ovarian-Cancer-at-the-International-Gynecologic-Cancer-Society-IGCS-2024-Annual-Meeting

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.