On April 2, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that it has begun treating patients in RASolute 303, a global Phase 3 clinical trial evaluating daraxonrasib as monotherapy and in combination with chemotherapy in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease predominantly driven by oncogenic RAS variants. RASolute 303 is designed to enroll patients irrespective of tumor RAS genotype.
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"Starting treatment of study participants in the RASolute 303 trial represents an important milestone for our daraxonrasib program and for patients with metastatic pancreatic cancer, a disease with substantial unmet medical need," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "In this trial, we are testing two biologically rational approaches—daraxonrasib as monotherapy and daraxonrasib in combination with chemotherapy—as two distinct, promising strategies to potentially improve patient outcomes. This trial underscores our commitment to advancing RAS(ON) inhibition into earlier lines of therapy, where we believe it can deliver significant benefit."
RASolute 303 (NCT07491445) is a global, randomized, open-label Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard-of-care gemcitabine and nab-paclitaxel in patients with previously untreated metastatic PDAC. In this trial, the company is enrolling patients who have not received prior systemic therapy for metastatic disease. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes.
Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials, including three trials in patients with PDAC and one in patients with non-small cell lung cancer (NSCLC).
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 are 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-driven 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 (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors.
(Press release, Revolution Medicines, APR 2, 2026, View Source [SID1234664153])