Revolution Medicines’ Breakthrough Drug Doubles Survival in Advanced Pancreatic Cancer

Revolution Medicines’ investigational drug daraxonrasib significantly extended survival for patients with previously treated metastatic pancreatic cancer, according to full results from its phase 3 RASolute 302 trial, confirming topline findings the company first reported in April.

Speaking with STAT during the ASCO meeting, Revolution Medicines CEO Mark Goldsmith said the FDA permitted the company to provide daraxonrasib to patients outside of clinical trials through an expanded access program, which is now active at hundreds of registered institutions, with the drug already shipping to participating sites. 

“Despite all the resources we’ve allocated to the expanded access program, we’ve also allocated a lot of resources to preparing a new drug application because that’s ultimately going to be the way to get drug available to far more patients,” he said at the STAT event.

Presented at ASCO 2026 and simultaneously published in the New England Journal of Medicine, the study found that patients who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for those treated with standard chemotherapy, nearly doubling overall survival in a disease with historically poor outcomes.

The findings position daraxonrasib as a potential new treatment option for metastatic pancreatic ductal adenocarcinoma (mPDAC), where effective therapies remain limited.

Pancreatic cancer is expected to account for about 3.2% of all new cancer diagnoses in the United States in 2026 but an estimated 8.4% of all cancer deaths, according to the National Cancer Institute. The age-adjusted incidence rate of pancreatic cancer has also been increasing, rising an average of 0.9% annually between 2014 and 2023.

The disease is typically treated with chemotherapy regimens including FOLFIRINOX or gemcitabine combined with nab-paclitaxel in the first line. For patients who remain candidates for further treatment, liposomal irinotecan (Onivyde)-based combinations are also available, with FDA approvals in 2015 for previously treated patients and in 2024 as a first-line option.

According to a CareSet analysis of Medicare Part B claims, largely second-line Onivyde generated fewer than 1,200 Medicare claims per month between May 2023 and May 2026, with the majority occurring in outpatient hospital settings.

Even with existing regimens, median progression-free survival is typically only three to four months and median overall survival ranges from six to seven months. 

Daraxonrasib, an oral RAS(ON) multi-selective inhibitor, substantially exceeded those benchmarks in its phase 3 RASolute 302 trial. At a median follow-up of 8.5 months, patients treated with daraxonrasib achieved a median overall survival of 13.2 months versus 6.7 months with chemotherapy. The drug also significantly delayed disease progression. Median progression-free survival was 7.3 months among patients whose tumors harbored RAS G12 mutations and 7.2 months in the overall study population, compared with 3.5 months and 3.6 months, respectively, in the chemotherapy group.

The international phase 3 trial enrolled 500 patients with previously treated mPDAC. Participants were randomly assigned to receive either daraxonrasib or investigator’s choice of standard chemotherapy. Most patients in both treatment arms had tumors carrying a RAS G12 mutation.

Researchers also reported a manageable safety profile, with no new safety signals identified during the study.

Unlike existing targeted therapies that primarily inhibit RAS signaling, daraxonrasib belongs to what Revolution Medicines CEO Goldsmith describes as a “novel class of catalytic inhibitors” that can turn off the cancer-driving KRAS protein to stop cancer growth.

The FDA has granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation, and the drug has been selected for the FDA Commissioner’s National Priority Voucher pilot program, which entitles the drug to be reviewed in just one or two months.

Goldsmith also noted that the company has been advancing trials in first-line pancreatic cancer and non-small cell lung cancer.

For more detailed Medicare data on disease prevalence, treatment patterns, and utilization, contact CareSet.