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/ASCO: Revolution Med posts full Phase III pancreatic cancer data set for daraxonrasib
NEWS

ASCO: Revolution Med posts full Phase III pancreatic cancer data set for daraxonrasib

AllSci
2026/06/01Health
Revolution Medicines (Nasdaq: RVMD) [released](https://www.globenewswire.com/news-release/2026/05/31/3303919/0/en/Revolution-Medicines-Announces-ASCO-Plenary-Presentation-Highlighting-Unprecedented-Results-from-Pivotal-Phase-3-RASolute-302-Clinical-Trial-of-Daraxonrasib-in-Previously-Treated-M.html) the full Phase III dataset at this year's American Society of Clinical Oncology (ASCO) meeting showing that daraxonrasib, an oral RAS(ON) multi-selective inhibitor, cut the risk of death by 60% compared to standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The results confirm the [earlier release of topline figures](https://allsci.com/news/clinical-trials/revolution-medicines-daraxonrasib-nearly-doubles-os-in-phase-iii-pancreatic-cancer-trial/), and represent one of the largest survival improvements ever reported in a Phase III trial for previously treated metastatic PDAC and could establish the first broadly applicable targeted therapy for the majority of patients with RAS-driven disease. The [RASolute 302 trial](https://clinicaltrials.gov/study/NCT06625320) is a global, randomized Phase III study that enrolled 500 patients with previously treated metastatic PDAC, including those with RAS G12 mutations and a smaller group without an identified tumor RAS mutation. Patients were randomized to 300 mg oral daraxonrasib once daily or investigator's choice of four cytotoxic chemotherapy regimens. At a February 2026 data cutoff, median OS in the RAS G12 population reached 13.2 months with daraxonrasib versus 6.6 months with chemotherapy (HR 0.40; 95% CI: 0.30–0.54; p \< 0.0001); results in the intent-to-treat population were nearly identical. Median PFS doubled as well, at 7.3 versus 3.5 months in the RAS G12 group (HR 0.45; p \< 0.0001), and objective response rates were 33.2% versus 11.8%. The safety profile favored daraxonrasib on most measures: Grade 3 or higher treatment-related adverse events occurred in 43.6% of patients on daraxonrasib versus 57.5% on chemotherapy, and treatment discontinuation due to adverse events was strikingly low at 1.2% versus 11.2%. The most common high-grade events with daraxonrasib were rash and stomatitis; one fatal pneumonitis was reported. Results were simultaneously published in *The New England Journal of Medicine* as well as featuring in the ASCO 2026 Annual Meeting plenary session. [Daraxonrasib ](https://app.allsci.com/drugs/ASC-DR-0000000044840-1.0-1775585065)works by blocking the interaction between active RAS(ON) proteins — both wild-type and mutant forms — and their downstream effectors, a mechanistic approach distinct from the allele-specific KRAS(OFF) inhibitors that have reshaped lung cancer treatment. In the broader PDAC landscape, current second-line treatment largely relies on chemotherapy regimens such as Onivyde-based combinations and fluoropyrimidine-containing protocols, which typically deliver median overall survival measured in months rather than years. Biomarker-selected approvals for Merck's Keytruda (pembrolizumab) and AstraZeneca's Lynparza (olaparib) reach perhaps 10% of patients collectively. Cross-trial comparisons are limited, but no prior Phase III trial in any line of PDAC therapy has reported a median OS exceeding one year. Revolution Medicines intends to file a New Drug Application with the FDA under the Commissioner's National Priority Voucher program; an expanded access protocol is already open. --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/daraxonrasib-pancreatic-cancer-revolution-2)
Summary

Revolution Medicines (Nasdaq: RVMD) reported Phase III data showing that daraxonrasib, an oral RAS(ON) multi-selective inhibitor, cut the risk of death by...