Verastem Oncology announces positive interim data from Part A of the ongoing RAMP 201 international registration-directed Phase 2 study evaluating the safety and efficacy of avutometinib alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer, or LGSOC. The Company is also providing a regulatory update following a productive meeting with the FDA. "The interim data from the ongoing phase 2 RAMP 201 trial show that the combination of avutometinib with defactinib yields encouraging response rates with a well-tolerated safety profile in women with heavily pre-treated recurrent low-grade serous ovarian cancer," said Dr. Susana Banerjee, MBBS, global lead investigator of the study, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London. The objective of Part A of the RAMP 201 LGSOC study was to select the go forward regimen between avutometinib monotherapy or the combination of avutometinib and defactinib to be studied in Part B of the study. In addition, the efficacy was assessed in both KRAS mutant and KRAS wild type LGSOC. Part A randomized eligible patients to avutometinib monotherapy or the combination of avutometinib and defactinib. The combination of avutometinib and defactinib has been declared the go forward treatment regimen based on a higher rate of confirmed objective responses in a planned interim analysis with prespecified criteria. Overall, patients on the combination arm were heavily pretreated with an average of 4 prior systemic regimens, including prior platinum-based chemotherapy, endocrine therapy and bevacizumab in most patients and prior MEK inhibitor therapy in about 20% of patients. Of the 29 patients evaluable for response by blinded independent central review in the combination arm, the initial results showed a confirmed objective response rate of 28% in all patients and 27% vs 29% in KRAS mutant and KRAS wild-type LGSOC, respectively. The confirmed ORR for the monotherapy arm by BICR was 7% in evaluable patients. The overall disease control rate for the monotherapy arm by BICR was 90%. Target enrollment for the combination arm in RAMP 201 has been achieved. The Company is planning a RAMP 201 presentation at a scientific conference in mid-2023.
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