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REDWOOD CITY, Calif., June 23, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it has begun treating patients in RASolute 305, a global, randomized Phase 3 clinical trial evaluating zoldonrasib in combination with standard of care chemotherapy as a first line treatment in patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC).
“Pancreatic cancer is a RAS-driven disease, and we recently reported that daraxonrasib, our RAS(ON) multi-selective inhibitor, significantly improved overall survival, progression-free survival, response rates, and preservation of measures of quality of life versus standard of care chemotherapy in second line treatment of patients with metastatic pancreatic cancer across a range of RAS genotypes. These unprecedented findings provide important clinical validation of RAS(ON) inhibition in pancreatic cancer and support its evaluation earlier in the treatment course,” said Alan Sandler, M.D., chief development officer of Revolution Medicines.
“RAS G12D, the most common RAS subtype in pancreatic cancer, is associated with particularly poor clinical outcomes. Early studies of zoldonrasib, our oral RAS(ON) G12D-selective covalent inhibitor, have demonstrated encouraging clinical activity and safety. The RASolute 305 trial is evaluating whether combining zoldonrasib with chemotherapy can improve outcomes in first line treatment for metastatic RAS G12D pancreatic cancer. Both RASolute 305 and RASolute 303, a separate ongoing Phase 3 trial evaluating daraxonrasib in first line pancreatic cancer, reflect our broad commitment to studying RAS(ON) inhibitors with differentiated profiles across a range of unmet medical needs in pancreatic cancer,” added Dr. Sandler.
RASolute 305 (NCT07621718) is a global, randomized, double-blind placebo-controlled clinical trial evaluating zoldonrasib plus investigator’s choice of standard of care chemotherapy compared with placebo plus investigator’s choice of chemotherapy in patients with previously untreated metastatic RAS G12D PDAC. Investigator’s choice of chemotherapy includes modified FOLFIRINOX or gemcitabine plus nab-paclitaxel. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes.
About Pancreatic Cancer and Pancreatic Ductal AdenocarcinomaPancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people are diagnosed annually with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1
Pancreatic ductal adenocarcinoma, or PDAC, is the most common form of pancreatic cancer. Due to the lack of early symptoms and effective detection methods, approximately 80% of patients are diagnosed with advanced or metastatic disease. PDAC is the most commonly RAS-driven malignancy of all major cancers, with more than 90% of patients have tumors that harbor RAS mutations.2RAS G12D is the most prevalent RAS mutation subtype in PDAC, occurring in 40% of patients, and has been associated with poorer outcomes than RAS wild-type disease and certain other RAS-mutant subgroups.2-5Metastatic PDAC remains a leading cause of cancer-related death in the U.S., with a five-year survival rate of approximately 3%.6,7
About ZoldonrasibZoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS(ON) G12D mutation. RAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers.2Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the U.S., and no targeted therapy is currently approved for these patients.8Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.
About Revolution Medicines, Inc.Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visitwww.revmed.comand follow us onLinkedIn.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the broad potential of RAS(ON) inhibition, including in pancreatic cancer; the ability of daraxonrasib or zoldonrasib to improve patient outcomes; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied.
Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.
Revolution Medicines Media & Investor Contact:media@revmed.cominvestors@revmed.com
References
1Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024.CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.218202Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors.NPJ Precis Oncol.2022;6(1);91. doi:10.1038/s41698-022-00334-z3Yousef, A., Yousef, M., Chowdhury, S. et al. Impact of KRAS mutations and co-mutations on clinical outcomes in pancreatic ductal adenocarcinoma.NPJ Precis Oncol. 2024;8:27. https://doi.org/10.1038/s41698-024-00505-04Qian ZR, Rubinson DA, Nowak JA, et al. Association of Alterations in Main Driver Genes With Outcomes of Patients With Resected Pancreatic Ductal Adenocarcinoma.JAMA Oncol. 2018;4(3):e173420. doi:10.1001/jamaoncol.2017.34205Norton C, Shaw MS, Rubnitz Z, et al.KRASMutation Status and Treatment Outcomes in Patients With Metastatic Pancreatic Adenocarcinoma.JAMANetwOpen.2025;8(1):e2453588. doi:10.1001/jamanetworkopen.2024.535886Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges.Cell.2023;186(8):1729-1754. doi:10.1016/j.cell.2023.02.0147American Cancer Society. Survival rates for pancreatic cancer. Available at:https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html. Accessed June 2026.8Estimated using tumor mutation frequencies from Foundation Medicine Insights March 2022 and scaled to estimated patient numbers using cancer incidence from ACS Cancer Facts and Figures 2023.