In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings.
The pancreatic cancer community has declared that they wanted a revolution in a disease that has just a 13% survival rate five years after diagnosis. Today, Revolution Medicines delivered results that could very well change their world with a doubling of survival in an advanced form of the disease.
Revolution’s daraxonrasib improved progression-free survival and overall survival in the Phase 3 RASolute 302 trial that featured previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC), according to a Monday morning release.
The news sent Revolution’s shares up nearly 40% as the markets opened Monday to $134.80.
Daraxonrasib achieved overall survival of 13.2 months compared to 6.7 months for chemotherapy. While the data come from an interim analysis of the late-stage trial, Revolution has declared them final given the results and will now move to file for approval with regulatory agencies, including the FDA.
“These results represent a potentially transformative advance for patients and underscore daraxonrasib’s potential to redefine the treatment landscape,” Revolution CEO Mark Goldsmith said in a statement. He promised that the company is now “moving with urgency” to get the drug in for regulatory review around the world.
Revolution was granted a Commissioner’s National Priority Voucher for the asset in October 2025, which aims to accelerate the approval of certain medicines as selected by the FDA commissioner. The program speeds the approval process from 10-12 months to just one or two.
The results “indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer,” Brian Wolpin, professor of medicine at Harvard Medical School, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute and principal investigator for the RASolute 302 trial, said in a statement provided by Revolution.
“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,” Wolpin continued.
Pancreatic cancer is one of the toughest to fight, as it’s not typically found until the disease has advanced and spread. The U.S. five-year relative survival rate is about 13% across the various detection stages. Few treatments are available besides chemotherapy and surgery, both of which can be difficult for advanced tumors. Researchers have long been looking for an “Achilles heel” that could advance survival in the disease.
Daraxonrasib is an oral RAS(ON) multi-selective, non-covalent inhibitor that targets cancers that are driven by RAS mutations, which are typically seen in PDAC, non-small cell lung cancer (NSCLC) and colorectal cancer. The pill is being developed in four Phase 3 clinical trials that are expected to underpin regulatory applications.
Besides RASolute 302, Revolution kicked off treatment in RASolute 303 earlier this month, which features patients with previously untreated metastatic PDAC. Daraxonrasib will be tested alone and in combination with chemotherapy in that trial. Daraxonrasib is also being tested in a late-stage trial for patients with NSCLC.
