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The combination of the RAF/MEK clamp avutometinib and the FAK inhibitor defactinib shrank tumours in about a third of women with recurrent low-grade serous ovarian cancer and in 44 percent of those with KRAS mutations, leading to the first approval specific to this disease.
Phase 2 study of 115 patients with recurrent low-grade serous ovarian cancer treated with avutometinib alone or with defactinib; the combination was selected for expansion.
In the combination arm, objective response was 31 percent overall and 44 percent in KRAS-mutant tumours (17 percent in KRAS wild-type), with median duration of response of 31 months and median progression-free survival of 12.9 months overall; toxicity included creatine kinase elevation, nausea and rash.
Avutometinib plus defactinib is approved for KRAS-mutant recurrent low-grade serous ovarian cancer, making KRAS testing a routine part of managing the disease; RAMP 301 is comparing it with standard therapy.