Revolution Medicines’ Daraxonrasib Phase 1/2 Data Show Durable Responses, OS Benefit
Revolution Medicines published Phase 1/2 trial data in the New England Journal of Medicine showing daraxonrasib yielded durable responses and manageable safety in previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma. Those findings underpinned the global, randomized Phase 3 RASolute 302 trial, which reported an unprecedented overall survival benefit.
1. NEJM Publication of Phase 1/2 Data
Revolution Medicines reported that daraxonrasib demonstrated promising antitumor activity, durable responses and an acceptable safety profile in the Phase 1/2 cohort of previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma, leading to publication in the New England Journal of Medicine.
2. Initiation and Topline of RASolute 302
Building on the Phase 1/2 findings, the company initiated RASolute 302, a global, randomized Phase 3 registrational trial in second-line metastatic PDAC. Topline results from this trial showed an unprecedented overall survival benefit for daraxonrasib versus standard cytotoxic chemotherapy.
3. Ongoing Registrational Programs
Daraxonrasib also holds Breakthrough Therapy and Orphan Drug designations from the FDA and is being evaluated in three additional global Phase 3 trials across earlier-line PDAC and metastatic RAS mutant non-small cell lung cancer.