Revolution Medicines Phase 3 Results Advance Treatment

Revolution Medicines (RVMD) announced on April 13, 2026, that its Phase 3 trial showed daraxonrasib significantly improved survival in previously treated metastatic pancreatic ductal adenocarcinoma. The company plans to seek U.S. approval through a New Drug Application (NDA) filed under a Commissioner's National Priority Voucher and will pursue global regulatory submissions.

Phase 3 Trial Results and Design

The company’s 8-K filing reported topline results from RASolute 302, a randomized Phase 3 trial comparing 300 mg daily oral daraxonrasib with standard intravenous chemotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma. Median overall survival was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001), indicating a 60% reduction in the risk of death. The trial met all primary and key secondary endpoints, which were declared final at the first interim analysis.

Progression-free survival was described as statistically significant and clinically meaningful. Daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals reported.

Regulatory Plans and Pipeline Development

Revolution Medicines said it will file an NDA with the FDA under a Commissioner's National Priority Voucher, which it received in October 2025. This designation is intended to shorten FDA review from the standard 10–12 months to about one to two months. The company also plans global regulatory filings. Full data will be presented at the American Society of Clinical Oncology meeting at the end of May 2026.

The company is expanding its late-stage program. Enrollment began in April 2026 for RASolute 303, a Phase 3 first-line metastatic pancreatic cancer study testing daraxonrasib as monotherapy and in combination with chemotherapy. Earlier first-line combination data showed a 55% overall response rate. Phase 3 trials are also underway in non-small-cell lung cancer. Revolution Medicines is advancing a second RAS inhibitor, zoldonrasib, toward Phase 3 for first-line pancreatic cancer with the G12D mutation and plans a late-stage study in KRAS G12C non-small-cell lung cancer.

The company cited the magnitude of the survival gain and the strong hazard-ratio signal as the basis for declaring endpoints final early and moving quickly toward regulatory submissions.

"These results represent a potentially transformative advance for patients," said Mark Goldsmith, M.D., Ph.D., chief executive officer of Revolution Medicines.