On May 6, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that The New England Journal of Medicine (NEJM) has published a report describing data from the Phase 1/2 clinical trial evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma (PDAC). The promising Phase 1/2 findings provided important insights supporting initiation of the company’s global, randomized Phase 3 registrational trial, RASolute 302. Revolution Medicines recently announced positive topline results from the RASolute 302 clinical trial showing an unprecedented overall survival benefit with daraxonrasib compared to standard of care cytotoxic chemotherapy, consistent with the Phase 1/2 single-arm observations.
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"RAS mutations are a central driver of disease across multiple solid tumors, including particularly pancreatic ductal adenocarcinoma. There is significant room for improvement in outcomes over current standard of care — cytotoxic chemotherapies that are not targeted to these underlying RAS cancer drivers," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile, in patients with previously treated metastatic RAS mutant PDAC. These results, along with those from our Phase 3 trial, RASolute 302, strengthen our confidence in daraxonrasib’s potential to establish an important new treatment option for patients with pancreatic cancer and other RAS-addicted cancers."
The data published in NEJM reflect outcomes in the PDAC cohort from the RMC-6236-001 trial (NCT05379985), an open-label, multicenter Phase 1/2 trial evaluating daraxonrasib monotherapy in patients previously treated for metastatic solid tumors harboring RAS mutations.
In addition to RASolute 302, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC in earlier treatment lines and those with metastatic RAS mutant non-small cell lung cancer.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people are diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1
Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most common RAS-addicted malignancy of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3,4
About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.
Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.
(Press release, Revolution Medicines, MAY 6, 2026, View Source [SID1234665197])