Pancreatic cancer drug doubles survival in landmark trial

Revolution Medicines ↗3.31% presented full Phase 3 trial data at ASCO showing daraxonrasib doubled median overall survival to 13.2 months versus chemotherapy.biopharmadive
The once-daily pill targets KRAS mutations found in over 90% of pancreatic cancers and met all primary and secondary endpoints, drawing a standing ovation at the conference.oncologynewscentral
Daraxonrasib is not yet FDA-approved but is available through an expanded access program while the company seeks regulatory clearance.pancan

Daraxonrasib Doubles Pancreatic Cancer Survival in Landmark Trial Presented at ASCO

Revolution Medicines unveiled full results from its Phase 3 RASolute 302 trial at the American Society of Clinical Oncology annual meeting this past weekend, confirming that the experimental drug daraxonrasib doubled median overall survival for patients with previously treated metastatic pancreatic cancer compared to standard chemotherapy.

The data, published simultaneously in The New England Journal of Medicine, showed that patients receiving daraxonrasib lived a median of 13.2 months, compared with 6.6 months for chemotherapy recipients among those with RAS G12 mutations — a 60% reduction in the risk of death. The presentation by lead investigator Brian M. Wolpin of the Dana-Farber Cancer Institute drew a standing ovation from the packed auditorium.biopharmadive

Trial Details

The global, randomized trial enrolled approximately 500 patients with metastatic pancreatic ductal adenocarcinoma across more than 60 sites worldwide. Patients received daraxonrasib as a second-line treatment after prior chemotherapy. The trial met all primary and key secondary endpoints.pancan

Progression-free survival also doubled: 7.3 months with daraxonrasib versus 3.5 months with chemotherapy in the RAS G12 population. Confirmed objective response rates were 33.2% for daraxonrasib compared with 11.8% for chemotherapy. The survival benefit held across the overall population regardless of specific RAS mutation type.oncologynewscentral

Safety and Tolerability

The drug showed a more manageable side-effect profile than chemotherapy. Grade 3 or higher treatment-related adverse events occurred in 43.6% of daraxonrasib patients versus 57.5% in the chemotherapy arm. Only 1.2% of daraxonrasib recipients discontinued treatment due to adverse events, compared with 11.2% in the chemotherapy group. The most common side effects were rash, diarrhea, and stomatitis.oncologynewscentral

A New Standard of Care

The results mark the first time any drug intervention has produced median survival beyond one year for patients with previously treated metastatic pancreatic cancer, according to Alan Sandler, Revolution Medicines’ chief development officer.biopharmadive

“These results are landscape-changing for metastatic pancreatic cancer patients with a KRAS mutation,” said Rachna Shroff, hematology and oncology chief at the University of Arizona Cancer Center.biopharmadive

Daraxonrasib, a once-daily oral pill that targets the active form of the KRAS protein driving tumor growth in more than 90% of pancreatic cancers, has received Breakthrough Therapy designation from the FDA. While not yet approved, the drug is currently available to eligible U.S. patients through an expanded access program authorized by the FDA in May 2026.mskcc