Revolution Medicines disclosed that its Phase 3 RASolute 302 study of the oral RAS(ON) inhibitor daraxonrasib met all primary and key secondary endpoints in patients with metastatic pancreatic ductal adenocarcinoma. The intent‑to‑treat population achieved a median overall survival of 13.2 months versus 6.7 months for standard chemotherapy, a 60 % reduction in the risk of death and a hazard ratio of 0.40 (p < 0.0001). The study also met progression‑free survival endpoints, although specific median PFS values were not disclosed.
The trial enrolled patients with a broad spectrum of RAS mutations—including G12, G13 and Q61 variants—as well as patients without a detectable mutation, underscoring daraxonrasib’s pan‑RAS activity. The inclusion of mutation‑negative patients demonstrates the drug’s potential to benefit a wider patient population than other RAS inhibitors that target only specific mutations such as G12C.
Revolution Medicines plans to submit the data to the U.S. Food and Drug Administration under the Commissioner’s National Priority Voucher program, a pathway that could accelerate review and approval. The results represent the first time a RAS(ON) inhibitor has shown a clinically meaningful survival advantage in a solid tumor with no approved targeted therapy, positioning daraxonrasib as a potential first‑in‑class treatment for pancreatic cancer.
The trial’s success could unlock a multi‑billion‑dollar market, as pancreatic cancer accounts for more than 90 % of RAS‑driven tumors. Revolution Medicines is supported by a partnership with Royalty Pharma that provides up to $2 billion in committed capital, and the company reported $2.1 billion in cash, cash equivalents and marketable securities as of March 31 2025, sufficient to fund operations into the second half of 2027. In Q4 2025 the company posted an earnings per share of –$1.86, missing estimates, and in Q1 2025 it reported a net loss of $213.4 million. R&D expenses rose to $987.3 million in 2025 from $592.2 million in 2024, reflecting continued investment in daraxonrasib and other pipeline assets.
Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, said, “In this pivotal trial, daraxonrasib as a targeted medicine delivered a dramatic improvement in overall survival in patients with previously treated metastatic pancreatic cancer compared to standard of care chemotherapy, consistent with earlier findings. These results represent a potentially transformative advance for patients and underscore daraxonrasib's potential to redefine the treatment landscape.” He added that the company is “moving with urgency” to get the drug in for regulatory review around the world. Principal investigator Brian M. Wolpin, M.D., M.P.H., commented, “The widely anticipated results of this study indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment, typically chemotherapy. 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.”
The company’s regulatory strategy will now focus on submitting the data to the FDA and other global authorities, with the expectation that the National Priority Voucher program could shorten the review timeline. In addition, Revolution Medicines plans to accelerate the launch of additional Phase 3 programs in lung and colorectal cancers, leveraging the platform’s pan‑RAS activity to address other RAS‑driven malignancies.
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