Daraxonrasib Nearly Doubles Survival for Advanced Pancreatic Cancer in Phase 3 Trial

An international Phase 3 RASolute 302 trial enrolled 500 patients with metastatic pancreatic ductal adenocarcinoma who had progressed after prior chemotherapy. Participants received oral daraxonrasib 300 mg daily or standard chemotherapy. The study was randomized, open-label, and included participants from the United States, Europe, and Asia. Results were presented at ASCO 2026 and published in NEJM.

Newsweek

Over 90 % of pancreatic tumors carry activating KRAS mutations that drive uncontrolled proliferation, making the pathway a central therapeutic target. Daraxonrasib, a RAS(ON) multi-selective inhibitor, binds cyclophilin A, which then blocks KRAS signaling.

The Conversation

Daraxonrasib extended median overall survival to 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40, 60 % death-risk reduction). Progression-free survival was 7.3 months versus 3.5 months. Tumor shrinkage was observed in 31 % of patients versus 11 % with chemotherapy. The most common adverse event was rash (>86 %); other events included stomatitis, diarrhea, nausea, and vomiting. Treatment discontinuation due to side effects occurred in 1.2 % of daraxonrasib patients versus 11.2 % with chemotherapy.

The Conversation

Daraxonrasib is the first KRAS-targeted drug to improve survival, shifting treatment toward precision medicine. The FDA granted Breakthrough Therapy and Orphan Drug designations. Critics warn that cost, insurance coverage, and rash management may limit access. Oral daily dosing also avoids frequent infusion visits, a practical advantage for patients with limited mobility.

The Conversation

Revolution Medicines called the data a “major breakthrough.” ASCO’s chief medical officer described the results “much more than a home run.” ACS senior vice-president highlighted the historic shortage of effective options. The FDA’s Breakthrough Therapy and National Priority Voucher designations provide a fast-track pathway to approval.

Experimental Drug Doubles Survival Time For Pancreatic Cancer

Chemotherapy survival is reported as 6.6 months in some sources and 6.7 months in others. The open-label design may bias symptom reporting, and long-term outcomes, resistance mechanisms, and durability of response beyond median follow-up remain unknown.

New Scientist

• “These results represent a potentially transformative advance for patients and underscore daraxonrasib’s potential to redefine the treatment landscape,” — Mark Goldsmith, MD, CEO & Chairman, Revolution Medicines

HealthLine

• “These results are extremely promising since this drug doubled overall survival for patients with relapsed pancreatic cancer,” — Christina Annunziata, MD, Senior Vice President, Extramural Discovery Science, American Cancer Society

HealthLine

• “You can't stick anything to it. It just kind of slides off,” — Shubham Pant, MD, MD Anderson Cancer Center

Newsweek

• “Having treated pancreatic cancer for 16 years, I actually started crying in clinic. This is such an incredibly impactful study for our patients,” — Rachna Shroff, MD, Chief of Hematology/Oncology, University of Arizona Cancer Center

Newsweek

The FDA may grant approval, enabling commercial use. Ongoing trials test daraxonrasib earlier, in combination with chemotherapy, and in other RAS-driven cancers such as lung, colorectal, and ovarian.

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