ASCO26: Revolution's Daraxonrasib Phase III Data Reshapes Pancreatic Cancer Odds
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At ASCO26, Revolution Medicines presented Phase III data for daraxonrasib, demonstrating a dramatic overall survival benefit in previously treated pancreatic ductal adenocarcinoma. This analysis covers the trial results, regulatory milestones, and strategic implications for pharma teams and investors.
Revolutions pancreatic cancer story at ASCO26 is daraxonrasib. Phase 3 RASolute 302 nearly doubled median overall survival versus chemotherapy in previously treated metastatic PDAC, with results published in NEJM and spotlighted in the ASCO plenary.
Contents10 sections
Key Takeaways
- ITT median OS: 13.2 months daraxonrasib vs 6.7 months chemotherapy (HR 0.40).
- RAS G12 dual primary population showed similar OS benefit (13.2 vs 6.6 months).
- PFS roughly doubled (about 7.2–7.3 vs 3.5–3.6 months) with ORR about 31–33% vs 11%.
- Trial ID NCT06625320; oral RAS(ON) multi-selective inhibitor RMC-6236.
What did Revolution Medicines report in RASolute 302?
Revolution Medicines announced that oral daraxonrasib, a RAS(ON) multi-selective inhibitor, improved progression-free and overall survival versus intravenous investigator-choice chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma.
In the intent-to-treat population, median OS was 13.2 months versus 6.7 months (hazard ratio 0.40; p < 0.0001). The April 13, 2026 GlobeNewswire topline release called those PFS and OS results final based on the first analysis.
How was the Phase 3 trial designed?
NCT06625320 on ClinicalTrials.gov lists RASolute 302 as a global, randomized, open-label Phase 3 study of RMC-6236 versus investigator's choice of standard chemotherapy after one prior 5-FU- or gemcitabine-based line.
- Enrollment: about 500 participants.
- Experimental arm: daraxonrasib 300 mg orally once daily.
- Dual primary endpoints: OS and BICR-assessed PFS in the RAS G12 mutation subpopulation.
- Secondary endpoints include OS/PFS in the full ITT population and objective response.
What did ASCO26 and NEJM add?
Detailed results were presented as ASCO 2026 Plenary late-breaker LBA5 and published in The New England Journal of Medicine. Company briefing materials cite ORR 33.2% versus 11.8% in the RAS G12 population and treatment-related discontinuation of 1.2% versus 11.2% for chemotherapy.
The ASCO abstract record is available via Journal of Clinical Oncology LBA5.
What should BD and oncology strategy teams watch?
Regulators will scrutinize RAS-wild-type subgroups, quality-of-life consistency, and manufacturing scale-up for a daily oral agent. Competitive RAS(ON) and KRAS G12C/D programs will reprice second-line PDAC deal terms if approval follows.
What remains unproven?
Phase 3 superiority versus chemotherapy does not equal commercial standard-of-care status until labels, payer coverage, and first-line combinations are defined. Expanded-access activity and NDA timing under any voucher pathway remain company-guided until FDA posts an approval letter.
How do the RAS G12 and ITT populations compare?
RASolute 302 dual primary endpoints focused on patients with RAS G12 mutations, the most common oncogenic RAS class in PDAC. In that group, median OS was 13.2 months with daraxonrasib versus 6.6 months with chemotherapy, again with a hazard ratio of 0.40. Progression-free survival was 7.3 months versus 3.5 months.
The broader intent-to-treat population also included less common RAS variants and tumors without an identified RAS mutation. Survival and PFS benefits remained directionally consistent, which matters because pancreatic tumors are genetically diverse and second-line options are limited. Objective response rates near one-third on the oral RAS(ON) inhibitor contrast with roughly 11% on chemotherapy in reported analyses.
Safety narratives describe grade 3 or higher adverse events in about 62% of daraxonrasib patients versus about 70% on chemotherapy, with fewer treatment-related discontinuations on the investigational arm. Those differentials will influence supportive-care planning if the drug reaches routine practice.
For Asia-Pacific oncology networks, the practical next questions are access pathways, companion diagnostic needs for RAS genotyping, and whether oral daily dosing improves real-world adherence versus multi-agent IV chemotherapy after first-line failure in metastatic PDAC.
Those access questions will determine how quickly overall survival gains translate into regional standard-of-care shifts after any approval.
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Frequently Asked Questions
What did RASolute 302 show for overall survival?
In previously treated metastatic PDAC, daraxonrasib achieved median OS of 13.2 months versus 6.7 months for investigator-choice chemotherapy in the intent-to-treat population (HR 0.40; p<0.0001), per company and NEJM-linked reporting.
What is the ClinicalTrials.gov ID for RASolute 302?
NCT06625320. The Phase 3 study randomized about 500 patients with previously treated metastatic PDAC to oral daraxonrasib 300 mg daily or investigator-choice chemotherapy.
Where were the pivotal data presented?
Detailed results were presented as ASCO 2026 late-breaking Plenary abstract LBA5 and published in The New England Journal of Medicine (doi 10.1056/NEJMoa2605555).
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