Revolution Medicines' Daraxonrasib Phase 1/2 Data Published in NEJM
Revolution Medicines announced that The New England Journal of Medicine (NEJM) published data from its Phase 1/2 clinical trial evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma (PDAC). These promising findings supported the initiation of the company’s global, randomized Phase 3 registrational trial, RASolute 302, which recently announced positive topline results showing an unprecedented overall survival benefit. Daraxonrasib demonstrated promising clinical antitumor activity, durable responses, and an acceptable safety profile. The drug has received FDA Breakthrough Therapy and Orphan Drug Designations and is being evaluated in multiple Phase 3 trials.
Key Highlights
- The New England Journal of Medicine published Phase 1/2 data for daraxonrasib.
- Data showed promising clinical antitumor activity and durable responses in PDAC.
- Findings supported the initiation of the global Phase 3 RASolute 302 trial.
- RASolute 302 recently showed unprecedented overall survival benefit with daraxonrasib.
- Daraxonrasib holds FDA Breakthrough Therapy and Orphan Drug Designations.
- It was selected for the FDA Commissioner’s National Priority Voucher pilot program.
- Daraxonrasib is being evaluated in four global Phase 3 registrational trials.
- Over 90% of pancreatic cancer patients have tumors with RAS mutations.
Price Impact
More from RVMD