Daraxonrasib Yields Significant Survival Advantages vs Chemotherapy in Metastatic Pancreatic Cancer

Daraxonrasib (RMC-6236) generated statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) benefits vs standard-of-care (SOC) cytotoxic chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, according to data from the first interim analysis of the phase 3 RASolute 302 trial (NCT06625320).¹

In the intention-to-treat (ITT) population, patients who received daraxonrasib achieved a median OS of 13.2 months compared with 6.7 months among those who received chemotherapy (HR, 0.40; P < .0001). Daraxonrasib was also generally well tolerated with a manageable safety profile, and no new safety signals were reported.

“For patients with metastatic pancreatic cancer, new treatment options are urgently needed to increase survival time and improve quality of life [QOL],” Brian M. Wolpin, MD, MPH, a professor of medicine at Harvard Medical School, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute in Boston, Massachusetts, as well as the principal investigator for the RASolute 302 trial, stated in a news release. “The widely anticipated results of this study indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment, typically chemotherapy. I believe that this new approach is a very important advance for the field that I expect will be practice-changing for physicians and improve the care for patients with previously treated metastatic pancreatic cancer.”

Notably, all PFS and OS end point data from the first interim analysis are considered final.

Revolution Medicines, the developer of daraxonrasib, plans to include these data in a new drug application submission to the FDA and other global regulatory agencies. The data will also be submitted for presentation at the 2026 ASCO Annual Meeting.

“In this pivotal trial, daraxonrasib as a targeted medicine delivered a dramatic improvement in OS in patients with previously treated metastatic pancreatic cancer compared [with] SOC chemotherapy, consistent with earlier findings,” Mark A. Goldsmith, MD, PhD, chief executive officer and chairman of Revolution Medicines, added in the news release. “These results represent a potentially transformative advance for patients and underscore daraxonrasib’s potential to redefine the treatment landscape. We are moving with urgency toward global regulatory submissions and remain committed to rapidly advancing this therapy for patients with a broad range of RAS-addicted cancers. We are deeply grateful to the patients, families, investigators, and study teams whose participation made the RASolute 302 trial possible, and we look forward to sharing detailed results with the scientific and clinical communities.”

What is the design of RASolute 302?

This ongoing, global, randomized, controlled trial enrolled patients at least 18 years of age with pancreatic tumors harboring various RAS mutations (including G12D, G12V, and G12R), as well as those with no identified RAS mutation.^1,2 Patients needed to have an ECOG performance status of 0 or 1, measurable disease per RECIST 1.1 criteria, and adequate organ function.²

Patients were randomly assigned to receive daraxonrasib at 300 mg orally once daily, or investigator’s choice of intravenous cytotoxic chemotherapy.^1,2

PFS per blinded independent central review and OS in patients with RAS G12–mutated tumors served as the coprimary end points. Secondary end points included PFS and OS in the ITT population, which included all enrolled patients, encompassing those with RAS-mutated and RAS wild-type tumors; overall response rate, duration of response, and patient-reported QOL.

“We believe these results firmly validate our pioneering approach to targeting common RAS-addicted cancers through RAS(ON) inhibition,” Goldsmith concluded in the news release.¹ “This class of inhibitors reflects more than 15 years of investment in groundbreaking scientific research.”

References

1. Daraxonrasib demonstrates unprecedented overall survival benefit in pivotal phase 3 RASolute 302 clinical trial in patients with metastatic pancreatic cancer. News release. Revolutions Medicines. April 13, 2026. Accessed April 13, 2026. https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit
2. Phase 3 study of daraxonrasib (RMC-6236) in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) (RASolute 302). ClinicalTrials.gov. Updated December 12, 2025. Accessed April 13, 2026. https://clinicaltrials.gov/study/NCT06625320