BOSTON — September 24, 2026
Verastem Oncology announced that molecular profiling and tumor biomarker findings from the Phase 2 RAMP 201 trial of avutometinib plus defactinib in recurrent low-grade serous ovarian cancer (LGSOC) have been selected for a late-breaking oral presentation at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting in Montreal. The company will also present previously reported results from the RAMP 201J study in Japanese patients and an external control arm analysis comparing the combination with conventional care.
RAMP 201 Data to Highlight Molecular and Tumor Biomarkers
The late-breaking presentation, titled “Molecular Profiling and Tumor Biomarker Analysis of RAMP 201,” will examine molecular characteristics and tumor biomarkers from patients treated with avutometinib and defactinib. RAMP 201 was an adaptive, randomized, open-label Phase 2 trial evaluating avutometinib alone and in combination with defactinib in recurrent LGSOC. The selected combination regimen was avutometinib 3.2 mg twice weekly plus defactinib 200 mg twice daily, which was subsequently evaluated in expansion portions of the study. The presentation is scheduled for October 2, 2026, during the Rapid Orals – Rare Gynecologic Tumors Master Session.
Japanese Study and External Control Analysis Add Clinical Evidence
Previously reported findings from RAMP 201J, a Phase 2 study evaluating avutometinib plus defactinib in Japanese patients with recurrent LGSOC, will also receive a seminal oral presentation at IGCS 2026. Separately, an external control arm analysis will compare outcomes associated with the combination against conventional care in LGSOC. These analyses are intended to provide additional context on treatment outcomes across patient populations and against available standard-of-care approaches. The external control analysis is observational in nature and does not replace evidence from a randomized controlled comparison.
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AVMAPKI FAKZYNJA Combination Has FDA Accelerated Approval
The FDA approved AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules and defactinib tablets) in May 2025 for adults with KRAS-mutated recurrent LGSOC who have received prior systemic therapy. The approval was granted under the accelerated approval pathway based on tumor response rate and duration of response, with continued approval potentially contingent on verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301, an international Phase 3 confirmatory study evaluating the combination against standard chemotherapy or hormonal therapy in recurrent LGSOC with and without a KRAS mutation. Avutometinib and defactinib remain investigational for other uses and combinations described in the development program.
Source :Verastem Oncology press release
