Verastem (NASDAQ:VSTM) climbed ~131% on Friday after announcing that 45% of patients with ovarian cancer who received the experimental therapy avutometinib as part of a combination regimen indicated a decrease in tumor size in a Phase 2 trial.
The RAMP 201 trial is a Phase 2 registration-directed study designed to evaluate avutometinib alone and in combination with defactinib in recurrent low-grade serous ovarian cancer (LGSOC), a condition with no specific FDA-approved treatments.
Highlights of the update indicate that out of 29 patients who were evaluable for efficacy, tumor shrinkage was seen in 86%, and their confirmed objective response rates reached 45% (13/29; 95% CI: 26%-64%). The patients had undergone a median of 4 prior systemic regimens.
The most common treatment-related adverse events included nausea, vomiting, diarrhea, peripheral edema, and blurred vision, most of which were mild to moderate. 12% of patients discontinued the treatment due to adverse events.
Verastem (VSTM) plans to include RAMP 201 data in a future filing for accelerated approval with the FDA, and the company is in talks with the regulator to design a confirmatory trial, expected to start in H2 2023.