Topline phase 3 RASolute 302 results showed daraxonrasib, an oral RAS(ON) multiselective inhibitor, nearly doubled overall survival versus standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. The 501-patient trial enrolled across a range of RAS variants.
Clinical Considerations
- Median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy in the overall study population (HR 0.40, P<.0001)
- Trial included patients with and without identified tumor RAS mutations, though primary endpoints focused on RAS G12-mutated tumors
- Daraxonrasib is oral once-daily dosing, contrasting with intravenous standard cytotoxic chemotherapy in second-line PDAC
- A New Drug Application is planned based on these results, with full data due at ASCO 2026
Practice Applications
- Recognize daraxonrasib as a forthcoming targeted option for previously treated metastatic PDAC
- Integrate RAS mutation testing into PDAC molecular workup if not already standard
- Interpret topline survival data pending peer-reviewed publication and full ASCO presentation
- Monitor FDA review timeline and label specifications around RAS variant eligibility
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