On December 18, 2025 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who have received surgery and chemotherapy.
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Revolution Medicines RASolute 304 clinical trial logo
RASolute 304 is anticipated to enroll approximately 500 patients with PDAC harboring oncogenic RAS mutations who have undergone resection and completed perioperative chemotherapy. The trial will assess whether daraxonrasib can improve disease-free survival compared to observation. The primary endpoint in RASolute 304 is disease-free survival, and secondary endpoints include overall survival, safety, and tolerability.
"We are pleased to begin enrolling patients into RASolute 304, which expands the clinical evaluation of daraxonrasib into another important treatment setting for patients with RAS mutant pancreatic cancer," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "This trial enables us to investigate daraxonrasib even earlier in the treatment paradigm, which could potentially improve the rate of long-term disease-free survival in patients with resectable pancreatic cancer."
Daraxonrasib is currently being evaluated in four global Phase 3 clinical trials, including three trials in PDAC and a trial in locally advanced or 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 approximately 60,000 people will be diagnosed annually 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 commonly RAS-addicted 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 (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
(Press release, Revolution Medicines, DEC 18, 2025, View Source [SID1234661536])