Verastem presents two-year follow-up data for ovarian cancer therapy
Verastem Oncology (NASDAQ: VSTM) presented two-year follow-up data from its Phase 2 RAMP 201 clinical trial evaluating AVMAPKI FAKZYNJA combination therapy in patients with recurrent low-grade serous ovarian cancer at the Society of Gynecologic Oncology 2026 Annual Meeting.
The updated analysis, with a median follow-up of 24.9 months, showed that efficacy measures remained consistent with the primary analysis conducted more than 13 months prior. The median duration of response was 31.1 months overall, with patients who had KRAS mutations showing 31.1 months and those with KRAS wild-type showing 12 months. Median progression-free survival was 12.9 months overall.
Fifty-two percent of patients with KRAS mutations and 30 percent of patients with KRAS wild-type recurrent low-grade serous ovarian cancer remained on therapy for more than one year. The treatment maintained a 12 percent discontinuation rate due to adverse events, with no new safety signals observed during the extended follow-up period.
The FDA approved AVMAPKI FAKZYNJA CO-PACK in May 2025 for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy under accelerated approval. Continued approval may depend on verification of clinical benefit in a confirmatory trial.
Verastem also presented an exposure-response analysis demonstrating that the FDA-approved dose of avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily achieved the best therapeutic effect. The analysis included 158 patients with low-grade serous ovarian cancer from the FRAME and RAMP 201 studies for efficacy, and 303 patients from multiple studies for safety.
The company is conducting RAMP 301, a Phase 3 confirmatory trial evaluating the combination versus standard chemotherapy or hormonal therapy for recurrent low-grade serous ovarian cancer patients with and without KRAS mutations.
