Revolution Medicines Daraxonrasib Phase 3 Trial Shows Unprecedented OS
Revolution Medicines announced detailed positive results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The oral RAS(ON) multi-selective inhibitor demonstrated unprecedented improvements in overall survival (OS) and progression-free survival (PFS) compared to standard of care chemotherapy, meeting all primary and key secondary endpoints. Daraxonrasib also showed a manageable safety profile and significantly delayed deterioration in cancer-related pain, global health status, and quality of life. The company plans to submit these data to global regulatory authorities, including the U.S. FDA.
Key Highlights
- Daraxonrasib reduced risk of death by 60% in both RAS G12 and ITT populations.
- Median OS for daraxonrasib was 13.2 months vs. 6.6 months for chemotherapy in RAS G12 population.
- Median OS for daraxonrasib was 13.2 months vs. 6.7 months for chemotherapy in ITT population.
- Median PFS for daraxonrasib was 7.3 months vs. 3.5 months for chemotherapy in RAS G12 population.
- Median PFS for daraxonrasib was 7.2 months vs. 3.6 months for chemotherapy in ITT population.
- Grade 3 or higher TRAEs occurred in 43.6% with daraxonrasib vs. 57.5% with chemotherapy.
- Discontinuation due to TRAEs was 1.2% for daraxonrasib vs. 11.2% for chemotherapy.
- Company intends to submit data to global regulatory authorities, including US FDA.
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