Revolution Medicines Announces Breakthrough Phase 3 Results for Pancreatic Cancer Drug

Median overall survival nearly doubled — 13.2 months for daraxonrasib vs. 6.7 months for chemotherapy.

Revolution Medicines announced results from a Phase 3 clinical trial of its investigational oral drug daraxonrasib for patients with metastatic pancreatic cancer. The trial, known as RASolute 302, compared daraxonrasib to standard chemotherapy in patients whose cancer had progressed after a prior treatment.

Trial Results

Patients who received daraxonrasib had a median overall survival of 13.2 months, compared to 6.7 months for those on standard chemotherapy. The company reported that the drug reduced the risk of death by 60% compared to chemotherapy.

Key efficacy results from the RASolute 302 trial (n=500) include:

"This is the first RAS inhibitor in a large randomized trial for pancreatic cancer, and the results support daraxonrasib as a potential new standard of care." — Brian Wolpin, Dana-Farber Cancer Institute

Drug and Mechanism

Daraxonrasib is a daily oral medication (300 mg pill) that inhibits both mutant and wild-type RAS(ON) proteins by forming a complex with cyclophilin A. The drug targets RAS mutations, which are present in approximately 90% of pancreatic cancer cases and drive tumor growth.

Regulatory Status and Plans

Revolution Medicines plans to seek U.S. Food and Drug Administration (FDA) approval for daraxonrasib as a second-line treatment for patients whose cancer has progressed on another therapy. The company intends to use a Commissioner's National Priority Voucher to expedite the review process.

The FDA approved an expanded access program (compassionate use) for daraxonrasib on May 1, 2026, after the company submitted a request on April 28. The program provides the drug free-of-charge to patients with previously treated metastatic pancreatic ductal adenocarcinoma who have no other treatment options. Physicians must submit individual patient requests to Revolution Medicines, which forwards suitable applications to the FDA. Hospital monitoring boards oversee enrolled patients.

Revolution Medicines CEO Mark Goldsmith confirmed that the company has begun distributing the drug to physicians and patients under the expanded access program. He stated that the company is engaged in "a full-throttle effort" to submit a full application to the FDA.

A separate Phase 3 trial (RASolute 303) evaluating daraxonrasib as a first-line therapy for newly diagnosed patients is ongoing.

Safety Profile

The company reported that daraxonrasib showed a manageable safety profile with no new safety concerns observed. Common side effects include rash, stomatitis, nausea, and diarrhea. The company stated that rash, a known side effect, is generally manageable.

Background on Pancreatic Cancer

• Pancreatic cancer has a five-year survival rate of approximately 13-13.7%, the lowest among major cancers.
• The National Cancer Institute estimates 67,530 new cases and 52,740 deaths in the U.S. in 2026.
• Over 90% of pancreatic cancer cases involve KRAS mutations.
• Current second-line standard of care chemotherapy provides modest benefit.

Independent Expert Comment: Benjamin Weinberg, an associate professor of medicine at Georgetown University who was not involved in the study, described the survival data as "very impressive."

Statements from Company Executives and Investigators

Revolution Medicines CEO Mark Goldsmith described the outcomes as "dramatic, practice-changing" and "unprecedented," stating that no prior drug has shown an overall survival benefit greater than one year in a Phase 3 trial for pancreatic cancer. He said the results "usher in a new era of RAS-targeted medicines for pancreatic cancer, which has been exclusively treated with cytotoxic intravenous chemotherapy."

FDA Commissioner Marty Makary stated that the approval timeline for the expanded access program "reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer."

Market Response

Revolution Medicines' share price increased by more than 30% following the announcement of the trial results.

Individual Patient Accounts

Former U.S. Senator Ben Sasse (Nebraska), who was diagnosed with stage-four pancreatic cancer in December, disclosed that he is taking daraxonrasib. In a "60 Minutes" interview, he said the drug reduced his tumor volume by 76% and decreased his pain. He also discussed experiencing rash as a side effect. Revolution Medicines declined to comment on individual patient cases.

Amy Johnston, a 35-year-old pancreatic cancer patient who has completed chemotherapy and surgery and is currently in a clinical trial, stated she intends to seek daraxonrasib through the expanded access program if the trial fails.

Source and Presentation

The RASolute 302 trial results were presented at the American Society of Clinical Oncology (ASCO) 2026 annual meeting and published in the New England Journal of Medicine. The trial was funded by Revolution Medicines.