Clinical TrialApr 13, 2026, 08:02 AM
Revolution Medicines' Daraxonrasib Achieves 13.2-Month OS in Phase 3 PDAC Trial
AI Summary
Revolution Medicines announced positive topline results from its global, randomized, controlled Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma. The trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS). Daraxonrasib showed a median OS of 13.2 months compared to 6.7 months for standard of care chemotherapy, with a hazard ratio of 0.40. The company intends to include these data in a future New Drug Application submission to the U.S. Food and Drug Administration and other global regulatory authorities.
Key Highlights
- Daraxonrasib achieved a median overall survival (OS) of 13.2 months.
- Standard of care chemotherapy showed a median OS of 6.7 months.
- Hazard ratio for OS was 0.40 (p < 0.0001).
- Trial met all primary and key secondary endpoints, including PFS and OS.
- Company plans to submit data for a New Drug Application to the FDA.