Daraxonrasib Phase III trial showed 13.2-month median overall survival in metastatic pancreatic cancer
Daraxonrasib showed median overall survival of 13.2 months versus 6.7 months for chemotherapy in a Phase III trial in previously treated metastatic pancreatic adenocarcinoma. The once-daily pan-RAS(ON) inhibitor was generally well tolerated, and the company plans to seek FDA approval.
Revolution Medicines announced positive results from its Phase III clinical trial comparing its once-daily pill daraxonrasib with the current standard of care chemotherapy in patients with previously treated pancreatic adenocarcinoma that has spread beyond the pancreas. According to clinical trial results announced today, a new therapy that targets RAS mutations present in more than 90% of patients with pancreatic adenocarcinoma approximately doubles overall survival. According to a company press release, daraxonrasib demonstrated a median overall survival of 13.2 months versus 6.7 months for chemotherapy.
It was a global, randomized trial, meaning that patients from more than 60 locations around the world were randomly assigned to one of these two treatment groups. Overall survival measures the length of time from when treatment begins until death from any cause.
Daraxonrasib was generally well tolerated, with a manageable safety profile and with no new safety signals. Prior studies with daraxonrasib have shown that rash is the most common side effect, with mouth sores, diarrhea, nausea and vomiting also common.
For decades, RAS was considered "undruggable," meaning that there was no effective way to target RAS. RAS mutations, particularly in the KRAS gene, are found in over 90% of pancreatic cancer cases. Mutations in KRAS can "switch on" signals for constant cell growth, driving tumor formation and progression.
RMC-6236 is a non-covalent pan-RAS(ON) inhibitor from Revolution Medicines. RMC-6236 exerts its action via a "tri-complex" mechanism, gluing RAS to the ubiquitously expressed chaperone protein, cyclophilin A.
Additional data from this trial is expected to be presented at the American Society of Clinical Oncology Annual Meeting in late May 2026. The company has announced its intent to take its data to the U.S. FDA for approval, and daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review of therapies aligned with U.S. national health priorities. The RASolute 302 clinical trial has closed and is no longer enrolling patients.