Revolution Medicines (NASDAQ:RVMD) shares jumped 36% in pre-market trading Monday after the company reported positive topline results from its global Phase 3 RASolute 302 study.
The trial, evaluating the oral RAS-selective inhibitor daraxonrasib (RMC-6236), demonstrated a nearly twofold increase in survival for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
The study met its primary endpoint of overall survival (OS) with a median of 13.2 months for patients receiving once-daily daraxonrasib, compared to 6.7 months for those receiving standard-of-care intravenous chemotherapy.
This resulted in a highly significant hazard ratio of 0.40 (p < 0.0001), representing a 60% reduction in the risk of death.
The trial also successfully met key secondary endpoints, including progression-free survival (PFS) and objective response rate.
Pancreatic cancer remains one of the most aggressive and difficult-to-treat malignancies, characterized by a lack of effective options once first-line therapies fail.
The 13.2-month survival benchmark is viewed by oncology analysts as a transformative outcome in the second-line setting, where outcomes have historically been measured in weeks rather than months.
Revolution Medicines plans to pursue an accelerated regulatory path.
The company announced it will submit a New Drug Application (NDA) to the U.S. FDA under the Commissioner’s National Priority Voucher (CNPV) Pilot Program.
This innovative pathway is designed to reduce review times to as little as two months for therapies addressing critical national health priorities.
If granted, daraxonrasib could see a commercial launch before the end of 2026.
Meanwhile, the safety profile of daraxonrasib remained consistent with earlier Phase 1/1b data, with manageable side effects and low discontinuation rates compared to the chemotherapy arm.
The most common adverse events were rash and gastrointestinal toxicities, which were primarily Grade 1 or 2 in severity.