Revolution Medicines to Present Updated Phase 1 Clinical Data for Zoldonrasib in Patients with Previously Treated KRAS G12D Non-Small Cell Lung Cancer at the 2026 AACR Annual Meeting
REDWOOD CITY, Calif., April 19, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC). Results were highlighted in the official press program at the American Association for Cancer Research (AACR) Annual Meeting and will be featured in a plenary oral presentation today, April 19, 2026, at 1:30 p.m. PDT.
“Patients with RAS G12D non-small cell lung cancer remain a population with a significant unmet medical need for targeted therapeutic options,” said Jonathan Riess M.D., medical director of thoracic oncology at UC Davis Comprehensive Cancer Center and principal investigator for the RMC-9805-001 trial. “The manageable safety profile and evidence of clinical activity in this Phase 1 trial are encouraging and support the continued clinical development of zoldonrasib.”
“We believe these updated data further strengthen the profile of zoldonrasib as a potentially important targeted therapy for patients with RAS G12D non-small cell lung cancer where historical treatment options, such as chemotherapy, have offered limited benefit, and are often associated with considerable toxicity,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “The emerging profile supports advancing zoldonrasib across monotherapy and combination settings in lung cancer and other RAS G12D-driven cancers.”
Summary of Phase 1 Zoldonrasib Data at AACR 2026 (Abstract # CT021)
RMC-9805-001 is a multicenter, open-label, dose escalation and dose expansion Phase 1 trial designed to evaluate zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation. The data to be presented at the AACR Annual Meeting are as of a December 1, 2025 data cutoff, and included 40 patients with KRAS G12D NSCLC treated with zoldonrasib 1200 mg once daily, the recommended Phase 2 dose, and who were evaluable for safety. Efficacy analyses were conducted in a subset of patients with prior immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel treatment who had sufficient follow-up for response assessment (n=27).
Zoldonrasib was generally well tolerated and demonstrated a safety profile consistent with previously reported findings. Treatment-related adverse events (TRAEs) of any grade occurring in at least 15% of patients were nausea (43%), vomiting (33%), diarrhea (30%), and rash (18%). The majority of TRAEs were Grade 1 in severity. Grade 3 TRAEs occurred in 13% of patients and resolved following dose interruption; TRAEs led to treatment discontinuation in 5% of patients. No Grade 4 or Grade 5 TRAEs were observed. Zoldonrasib demonstrated a favorable mean dose intensity of 94%.
Zoldonrasib demonstrated encouraging clinical activity in patients with KRAS G12D NSCLC previously treated with immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel. Among this subset of patients (n=27), the confirmed objective response rate was 52% (confidence interval (CI): 32, 71) and the disease control rate was 93% (CI: 76, 99). Median time to response was 1.4 months and median duration of response was not yet estimable (95% CI: 8.3, not estimable). Median progression-free survival (PFS) was 11.1 months (95% CI: 5.3, not estimable), with an estimated 12-month PFS rate of 48% (95% CI: 27, 66). Overall survival (OS) data were immature at the time of analysis, and median OS was not yet reached with median potential follow-up of 13.1 months (range: 9.1–19.9). Estimated survival rate at 12 months was 73% (95% CI: 52, 86), suggesting encouraging early survival outcomes.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. KRAS G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.3
About Zoldonrasib
Zoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. KRAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers, and currently lacks an approved targeted therapy.4 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the United States.5 Zoldonrasib 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 visit www.revmed.com and follow us on LinkedIn.
Forward-Looking Statements
This 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 company’s development strategy and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; and the potential of zoldonrasib as a therapeutic option for RAS G12D-driven cancers.
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-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 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.
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1 American Cancer Society. What is Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed April 2026.
2 American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 2026.
3 Ricciuti B, Alessi JV, Elkrief A, et al. Dissecting the clinicopathologic, genomic, and immunophenotypic correlates of KRASG12D-mutated non-small-cell lung cancer. Ann Oncol. 2022;33(10): 1029-1040. doi:10.1016/j.annonc.2022.07.005
4 Lee 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-z
5 Estimated 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.
