CALIFORNIA: Revolution Medicines said on April 13 that its experimental pancreatic cancer drug daraxonrasib significantly extended survival in a pivotal late-stage trial, marking one of the strongest reported results to date for a targeted medicine in previously treated metastatic pancreatic ductal adenocarcinoma. The company said patients in the overall study population lived a median of 13.2 months on the once-daily oral drug, compared with 6.7 months for those who received standard intravenous chemotherapy, while the Phase 3 RASolute 302 study also met its progression-free survival endpoint.
The results came from a global, randomized, controlled trial in patients whose metastatic pancreatic cancer had already been treated, a setting with limited options and poor survival. Revolution Medicines said the first interim analysis was sufficient to make the progression-free survival and overall survival findings final for those endpoints. The company also reported that daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals, adding to the significance of the readout in a cancer that is often diagnosed late and remains difficult to treat.
Daraxonrasib is designed to inhibit RAS signaling, a major driver of pancreatic tumors. Revolution Medicines said more than 90% of patients with pancreatic ductal adenocarcinoma have tumors driven by RAS mutations, and the RASolute 302 trial enrolled patients with a broad range of RAS variants as well as some without an identified RAS mutation. In the intent-to-treat population, the company reported a hazard ratio for overall survival of 0.40, indicating a substantially lower risk of death relative to standard chemotherapy over the course of the study.
Trial Results And Disease Context
The trial compared 300 milligrams of daraxonrasib taken orally once a day with investigator’s choice of standard cytotoxic chemotherapy. The primary endpoints focused on progression-free survival and overall survival in patients whose tumors carried RAS G12 mutations, while secondary endpoints assessed those outcomes across all enrolled patients. Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer, and metastatic disease carries a particularly heavy burden because most patients are diagnosed after the cancer has already spread beyond the pancreas.
The U.S. Food and Drug Administration had already granted daraxonrasib Breakthrough Therapy Designation for previously treated metastatic pancreatic cancer with KRAS G12 mutations in 2025. Revolution Medicines also said the drug has FDA Orphan Drug Designation in that setting. Those designations do not amount to approval, but they place the drug within an expedited regulatory framework for serious diseases with high unmet need. The company identified daraxonrasib as an investigational medicine and said it is not approved by any regulatory authority in the United States or Europe.
Regulatory Status And Next Steps
Revolution Medicines said it intends to include the Phase 3 data in a future New Drug Application to the FDA and in filings with other regulators. The company also said it plans to present detailed findings at the 2026 American Society of Clinical Oncology annual meeting. The drug is also being evaluated in other global Phase 3 studies, including additional pancreatic cancer programs and one in non-small cell lung cancer, reflecting a broader effort to test whether RAS-targeted treatment can be applied across multiple tumor types.
For pancreatic cancer patients and clinicians, the immediate importance of the result lies in the magnitude of the survival gain reported in a randomized Phase 3 study, rather than in any change to current prescribing status. Daraxonrasib remains an investigational therapy, but the RASolute 302 outcome gives Revolution Medicines a completed pivotal dataset in a disease where effective second-line options have been limited and where new treatment advances have been scarce. – By Content Syndication Services.