REDWOOD CITY, Calif. – Revolution Medicines, a late-stage clinical oncology company, has announced groundbreaking positive topline results from its global, randomized Phase 3 RASOLUTE-302 clinical trial. The study, evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), demonstrated an unprecedented improvement in overall survival.
According to the company's announcement, daraxonrasib achieved a median overall survival (OS) of 13.2 months, significantly outperforming the 6.7 months observed in patients receiving standard chemotherapy. This translates to a hazard ratio of 0.40 (p < 0.0001), indicating a 60% reduction in the risk of death for patients treated with the novel therapy. The drug, a multi-selective inhibitor of RAS(ON) proteins, also met all primary and key secondary endpoints, including progression-free survival.
Pancreatic cancer is notoriously aggressive, with more than 90% of cases driven by mutations in RAS proteins, making it the most RAS-addicted of all major cancers. Dr. Brian M. Wolpin, principal investigator for the RASOLUTE-302 trial and director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, emphasized the urgent need for new treatment options. "The widely anticipated results of this study indicate that daraxonrasib provides a clear and highly meaningful step forward for patients," Dr. Wolpin stated.
Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, hailed the results as "unprecedented," noting that no prior drug has shown an overall survival benefit greater than one year in a Phase 3 trial for pancreatic cancer. The company plans to expedite regulatory submissions, potentially utilizing a Commissioner's National Priority Voucher to accelerate FDA approval. Daraxonrasib was generally well tolerated, exhibiting a manageable safety profile without new safety signals.
The positive outcome of RASOLUTE-302, which enrolled patients with a broad range of RAS variants, positions daraxonrasib as a potential "game-changer" in the treatment landscape for this challenging disease. Revolution Medicines is also advancing other Phase 3 trials for daraxonrasib in first-line metastatic and adjuvant pancreatic cancer settings, as well as in RAS-mutated non-small cell lung cancer, signaling a broad impact for its RAS-targeting pipeline.
