August 26, 2026: the U.S. FDA approved daraxonrasib (RASONQUE) for metastatic pancreatic adenocarcinoma, the first RAS-targeted therapy approved for pancreatic cancer. All news →

Phase 3 RASolute 302 meets its primary endpoint: overall survival significantly extended

Revolution Medicines announced an "unprecedented" overall survival benefit for daraxonrasib in the Phase 3 trial in previously treated metastatic pancreatic cancer: median OS 13.2 vs 6.7 months.

On April 13, 2026 Revolution Medicines announced that the Phase 3 RASolute 302 trial had met its primary and key secondary endpoints.

In the overall intent-to-treat population, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy, a hazard ratio of 0.40 (p < 0.0001) corresponding to a 60% reduction in the risk of death. Progression-free survival was also statistically significantly and clinically meaningfully improved.

The trial enrolled 500 patients at 59 sites in North America, Europe and Asia. Patients had received one prior line of chemotherapy and were randomised 1:1 to daraxonrasib 300 mg once daily or one of four investigator's-choice standard chemotherapy regimens.

Daraxonrasib was generally well tolerated with a manageable safety profile and no new safety signals. The company said it would submit a marketing application to the FDA as soon as possible and present the full data at an upcoming medical congress.

← Back to news Last updated: September 5, 2026
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