Revolution Medicines reports that its investigational drug daraxonrasib doubled the overall survival of patients with metastatic pancreatic cancer compared to standard chemotherapy, according to results from the Phase III RASolute 302 trial. These findings were published yesterday in The New England Journal of Medicine and presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
“In this trial, daraxonrasib redefined treatment expectations in previously treated metastatic pancreatic cancer by reducing the risk of death by 60% and increasing median overall survival to more than one year, a result not previously reported in any Phase III clinical trial in any line of therapy for this disease,” said Mark A. Goldsmith, MD, PhD, chief executive officer and chairman of Revolution Medicines.
Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest cancer diagnoses, with a five-year survival rate of 3%. Currently available therapies offer very limited benefits for these patients, especially for those who have already been treated with a first line of chemotherapy and continued to see tumor progression.
In over 90% of pancreatic tumors, mutations that result in an overactivation of RAS(ON) signaling are a major driver of cancer growth. Daraxonrasib is an oral drug designed to block a broad spectrum of wild type and mutant RAS variants. The RASolute 302 trial set out to compare the effects of a daily dose of daraxonrasib to a standard chemotherapy course in 500 patients with metastatic pancreatic cancer who had previously received a first line of chemotherapy.
Results show that daraxonrasib increased the median overall survival from 6.6 to 13.2 months, while boosting progression-free survival from 3.5 to 7.3 months. Notably, these effects were consistent regardless of whether the tumors carried RAS mutations. Serious side effects were reported less frequently by patients who received daraxonrasib, reducing the likelihood of a patient having to discontinue treatment due to side effects by 10 times.
“Daraxonrasib significantly elevates the survival bar in the treatment of one of the deadliest human cancers, while better preserving quality of life compared to chemotherapy,” said Goldsmith. “These striking results firmly support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer, and usher in a new era of RAS-targeted therapy for patients living with this disease.”
Revolution Medicines has stated its intention to submit this data to the FDA and other regulators to seek approval of daraxonrasib in this patient population. Three other Phase III trials are currently underway, evaluating the drug in patients with PDAC and metastatic non-small cell lung cancer.
“These results from the Phase III RASolute 302 trial of daraxonrasib represent a major milestone for patients facing metastatic pancreatic cancer,” said Brian M. Wolpin, MD, director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and principal investigator for the RASolute 302 trial.
“For many patients, second line chemotherapy provides modest benefits, and new treatments delivering more durable tumor control have been urgently needed. These results will change how scientists, clinicians, and patients think about treatment for pancreatic cancer, and support a new paradigm where RAS(ON) inhibition enters standard of care for patients with previously treated metastatic pancreatic adenocarcinoma.”
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