Drug pipeline
Phase 3 trial shows unprecedented survival benefit in metastatic pancreatic cancer
Revolution Medicines reported positive topline results from its pivotal phase 3 RASolute 302 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), a population with historically limited treatment options.
In the global, randomized study, once-daily oral daraxonrasib demonstrated statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival compared with standard-of-care IV cytotoxic chemotherapy. Median OS in the intent-to-treat population was 13.2 months with daraxonrasib vs. 6.7 months with chemotherapy, corresponding to a 60% reduction in the risk of death (hazard ratio, 0.40; p<0.0001).
The trial met all primary and key secondary endpoints at the first interim analysis, and the company said these results are considered final. Daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals reported.
“For patients with metastatic pancreatic cancer, new treatment options are urgently needed to increase survival time and improve quality of life,” said Brian M. Wolpin, MD, MPH, the study’s principal investigator and a professor of medicine at Harvard Medical School. He added that the findings represent “a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment.”
Daraxonrasib is a multi-selective RAS (ON) inhibitor designed to target both mutant and wild-type RAS signaling, a pathway implicated in the majority of pancreatic cancers. Based on the RASolute 302 data, Revolution Medicines plans to submit the results to global regulatory authorities, including the US FDA, as part of a future New Drug Application using the Commissioner’s National Priority Voucher pathway. The company also expects to present the findings at the 2026 American Society of Clinical Oncology Annual Meeting.