Verastem initiates RAMP 301 trial

Verastem announced that it has initiated its international confirmatory Phase 3 RAMP 301 trial, evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer, or LGSOC. RAMP 301 is the confirmatory study required by the FDA for the combination of avutometinib and defactinib to potentially receive full approval for the treatment of recurrent LGSOC. The company intends to submit an accelerated approval new drug application, or NDA, for the combination of avutometinib and defactinib based on mature data from the Company’s Phase 2 registration-directed RAMP 201 trial, together with the results of the investigator-initiated FRAME trial. The company recently reported results of Part A of the RAMP 201 trial, including confirmed objective response rates, or ORR, by blinded independent central review of 45% with a response rate and safety profile consistent with previous studies.