Verastem Oncology’s combination therapy has shown durability in patients with recurrent low-grade serous ovarian cancer (LGSOC).
The data, presented during an oral plenary session at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancers, taking place in San Juan, Puerto Rico, shows two-year durability with the Avmapki and Fakzynja (avutometinib capsules; defactinib tablets) combination.
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In the analysis, which builds on previous data, there was a median duration of response (mDoR) of 31.1 months and a median progression-free survival (mPFS) of 12.9 months.
Specifically, in KRAS mutation (mt) patients, there was a mDoR of 31.1 months and mPFS of 19.6 months, while patients who were KRAS wild-type (wt) had a mDoR of 12 months and mPFS of 12.7 months.
50% of patients with KRAS-mutated and 30% with KRAS wild-type LGSOC remained on therapy for more than one year. Adverse events (AEs) were consistent with the primary analysis, with no new safety signals observed, and a 12% discontinuation rate due to AEs.
Dr Rachel Grisham, RAMP 201 presenting investigator, section head, Ovarian Cancer at Memorial Sloan Kettering Cancer Center (MSK), said: “Patients who remained on treatment with avutometinib plus defactinib for two years were able to maintain the same level of response and duration of therapy as seen in the primary analysis, suggesting that patients can stay on the combination for a long period of time, derive benefit and have manageable toxicity during long-term administration of these medications. As we approach the one-year FDA approval anniversary of avutometinib in combination with defactinib, this analysis reinforces progress in bringing a durable and clinically meaningful option to patients.”
Efficacy analyses included patients with LGSOC from the FRAME (NCT03875820) and RAMP 201 (NCT04625270) studies, while safety analyses included a broader population from the FRAME, RAMP 201, and RAMP 202 (NCT04620330) trials.
The combination of Avmapki and Fakzynja was granted accelerated approval by the US Food and Drug Administration (FDA) on 8 May 2025 for use in patients with KRAS-mutated LGSOC who received at least one prior systemic therapy.
GlobalData, parent company of Clinical Trials Arena, estimates that the value of the ovarian cancer market for the seven major pharmaceutical markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) in 2022 was $3.3bn, with 58% of sales generated in the US. By the end of the 2031 forecast period, GlobalData projects that ovarian cancer sales in the 7MM will reach $4.1bn.
