Revolution Medicines announced on Apr. 13 that its experimental drug daraxonrasib doubled overall survival for patients with advanced pancreatic ductal adenocarcinoma (PDAC) in a Phase 3 clinical trial.
Pancreatic cancer is known for its low five-year survival rate of about 13 percent, and few treatment options exist for patients with advanced disease. The new results from Revolution’s RASolute 302 trial could offer hope to patients who have already undergone prior treatments.
According to the company, daraxonrasib achieved an overall survival of 13.2 months compared to 6.7 months for chemotherapy among previously treated metastatic PDAC patients. The findings come from an interim analysis but are considered final by Revolution, which plans to file for regulatory approval with agencies including the U.S. Food and Drug Administration (FDA).
“These results represent a potentially transformative advance for patients and underscore daraxonrasib’s potential to redefine the treatment landscape,” Revolution CEO Mark Goldsmith said in a statement. He also said the company is “moving with urgency” to submit the drug for regulatory review worldwide.
Brian Wolpin, professor of medicine at Harvard Medical School and principal investigator of the RASolute 302 trial, said in a statement provided by Revolution: “The results indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer.” Wolpin added, “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.”
Daraxonrasib is described as an oral RAS(ON) multi-selective inhibitor targeting cancers driven by RAS mutations commonly found in PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. It is being studied across four Phase 3 trials intended to support regulatory submissions.
The company also reported starting another late-stage study earlier this month—RASolute 303—for previously untreated metastatic PDAC cases, testing daraxonrasib alone or combined with chemotherapy. Daraxonrasib is under investigation in NSCLC as well.
Revolution Medicines was granted a Commissioner’s National Priority Voucher by the FDA commissioner in October 2025 aimed at accelerating approval timelines from up to one year down to one or two months.
