Verastem Oncology has reported primary analysis data from the two-part multicentre Phase II RAMP 201 trial, demonstrating that avutometinib plus defactinib showed a confirmed overall response rate (ORR) of 31% in treating recurrent low-grade serous ovarian cancer (LGSOC) patients.
The analysis was published in the Journal of Clinical Oncology (JCO).
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The parallel cohort, adaptive, open-label, randomised study assessed avutometinib alone and in conjunction with defactinib in those with recurrent LGSOC.
These patients had undergone a median of three previous therapy lines, including hormonal therapy, chemotherapy, bevacizumab, and MEK inhibitors.
Part A of the trial determined the choice of the go-forward regimen, which was the combination therapy against avutometinib alone, based on ORRs.
Parts B and C, the trial’s expansion phases, assessed the safety and efficacy of the go-forward regimen of 3.2mg of avutometinib bi-weekly, and 200mg of defactinib twice a day.
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By GlobalDataPart D of the trial assessed a low dose of the combination to inform the reduction of the individualised dose.
The data published stated that the combination resulted in an ORR of 31% in 109 evaluable subjects in the trial.
The response rate was also higher in those with a KRAS mutation, at 44%, compared to 17% in KRAS wild-type patients.
The median duration of response (DOR) was reported to be 31.1 months across all subjects, with similar results seen in the KRAS mutant population.
Despite this, the KRAS wild-type population had a shorter median DOR of 9.2 months. Median progression-free survival (PFS) was 12.9 months for all subjects, extending to 22 months in the KRAS mutant population and 12.8 months in the KRAS wild-type population.
The disease control rate (DCR) at six months or more was 61% in the total population, with a higher rate of 70% in the KRAS-mutated group and 50% in the KRAS wild-type group.
Most patients, regardless of KRAS mutation status, experienced some minimisations in target lesions.
Last year, Verastem announced the dosing of the first subject with GFH375/VS-7375 as part of a Phase I/II trial in China.
