Verastem finalizes design for confirmatory trial of Avutometinib and Defactinib

Verastem Oncology “announced that it has finalized with the FDA the design of its confirmatory Phase 3 trial to evaluate the combination of avutometinib and defactinib for the treatment of recurrent low-grade serous ovarian cancer, or LGSOC. RAMP 301, a randomized global confirmatory trial, will evaluate the efficacy and safety of avutometinib and defactinib versus standard of care chemotherapy and hormonal therapy in patients with recurrent LGSOC. RAMP 301 is expected to begin enrollment in the second half of this year. RAMP 301 is the follow-up confirmatory study for full approval in recurrent LGSOC. The Company intends to file for Accelerated FDA Approval for the combination of avutometinib and defactinib based on mature data from the Company’s Phase 2 registration-directed RAMP 201, together with the results of the investigator-initiated FRAME trial. The Company recently reported results of Part A of RAMP 201 including confirmed objective response rates by blinded independent central review of 45% with a tolerable safety profile.”