REDWOOD CITY, Calif., May 31, 2026
Revolution Medicines has announced unprecedented results from its pivotal Phase 3 RASolute 302 clinical trial, demonstrating that daraxonrasib, an investigational oral RAS(ON) multi-selective inhibitor, significantly improved survival outcomes in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The landmark findings were presented during a late-breaking ASCO 2026 Plenary Session and simultaneously published in The New England Journal of Medicine, highlighting a potential breakthrough for one of the deadliest forms of cancer. The global randomized trial met all primary and key secondary endpoints, showing statistically significant improvements in overall survival (OS), progression-free survival (PFS), objective response rates, and patient-reported quality of life compared with standard chemotherapy.
Daraxonrasib Delivers Historic Survival Benefit in Pancreatic Cancer
The Phase 3 RASolute 302 study enrolled 500 patients with previously treated metastatic PDAC and compared once-daily oral daraxonrasib against investigator-selected standard chemotherapy regimens. Results revealed a remarkable 60% reduction in the risk of death, establishing a new benchmark in pancreatic cancer treatment. Patients receiving daraxonrasib achieved a median overall survival of 13.2 months, compared with approximately 6.6 to 6.7 months for chemotherapy-treated patients.
The trial also demonstrated a substantial improvement in progression-free survival, with median PFS reaching 7.2 to 7.3 months versus 3.5 to 3.6 months in the chemotherapy arm. Objective response rates were nearly three times higher among daraxonrasib-treated patients, further underscoring the therapy’s robust anti-tumor activity. Investigators described the results as unprecedented in metastatic pancreatic cancer, a disease historically associated with extremely poor outcomes and limited treatment options.
Novel RAS(ON) Inhibition Opens New Era for Targeted Oncology
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Daraxonrasib represents the first investigational therapy from a new class of RAS(ON) multi-selective inhibitors designed to target a broad spectrum of RAS-driven cancers. RAS signaling abnormalities are present in more than 90% of pancreatic cancers, making the pathway one of the most important therapeutic targets in oncology. Unlike traditional approaches, daraxonrasib suppresses both wild-type and mutant RAS proteins, addressing diverse RAS variants commonly found in pancreatic tumors.
The study demonstrated benefits across both RAS G12-mutated populations and the broader intent-to-treat patient population, suggesting broad applicability of the treatment. Industry experts noted that the results validate years of research into direct RAS inhibition and may establish a new treatment paradigm not only for pancreatic cancer but potentially for other RAS-driven malignancies, including lung and colorectal cancers.
Improved Quality of Life and Favorable Safety Profile
Beyond extending survival, daraxonrasib demonstrated meaningful benefits in patient quality of life. Patients reported significantly delayed deterioration in cancer-related pain, overall health status, and daily functioning compared with those receiving chemotherapy. The investigational therapy also showed a manageable safety profile, with fewer severe treatment-related adverse events and substantially lower treatment discontinuation rates. Only 1.2% of patients discontinued daraxonrasib due to treatment-related side effects, compared with 11.2% in the chemotherapy group.
These findings suggest that patients may not only live longer but also maintain a better quality of life during treatment. Revolution Medicines plans to submit the data to global regulatory authorities, including the U.S. FDA, as part of a future New Drug Application, potentially paving the way for a new standard of care in previously treated metastatic pancreatic cancer. The results mark one of the most significant advances in pancreatic cancer therapy in recent years and reinforce the growing promise of precision oncology approaches targeting RAS-driven disease.
Source: Revolution Medicines press release
