Revolution Medicines to Present Updated Elironrasib Safety and Efficacy Data in Patients with KRAS G12C Non-Small Cell Lung Cancer Following Treatment with a KRAS(OFF) G12C Inhibitor

Rhea-AI Summary

Revolution Medicines (Nasdaq: RVMD) reported updated clinical results for elironrasib in previously treated KRAS G12C NSCLC patients who had received prior KRAS(OFF) G12C inhibitors, highlighted at the AACR-NCI-EORTC Symposium (Oct 23-25, 2025).

As of the Aug 4, 2025 cutoff (n=24), elironrasib at 200 mg BID showed a confirmed objective response rate 42% (95% CI: 22-63), disease control rate 79%, median duration of response 11.2 months, median PFS 6.2 months, and 12-month OS rate 62%. In July 2025 elironrasib received Breakthrough Therapy Designation for certain KRAS G12C NSCLC patients.

Positive

• ORR 42% in prior OFF-inhibitor KRAS G12C NSCLC patients
• DCR 79% indicating broad disease control
• Median DOR 11.2 months showing durable responses
• Received Breakthrough Therapy Designation in July 2025

Negative

• Small dataset: n=24 limits statistical certainty
• Heavily pretreated population: median 3 prior lines
• Median OS not yet reached and follow-up limited

REDWOOD CITY, Calif., Oct. 22, 2025 (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 clinical data for elironrasib, a RAS(ON) G12C-selective inhibitor, in previously treated patients with KRAS G12C non-small cell lung cancer (NSCLC) who had received a prior KRAS(OFF) G12C inhibitor. These results will be highlighted in an oral presentation at the AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics in Boston, October 23-25.

“The compelling clinical activity, durable response and acceptable tolerability profile seen with elironrasib underscore the potential of this differentiated RAS(ON) G12C-selective inhibitor, including in patients who have progressed on G12C(OFF) inhibitors,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “These findings reinforce the promise of our RAS(ON) inhibitor platform to deliver a range of therapies that target the active, GTP-bound state of RAS proteins with the potential to create new global standards of care.”

As of the August 4, 2025 data cutoff date, patients with KRAS G12C NSCLC, who had received prior therapy with a KRAS(OFF) G12C inhibitor, were treated with elironrasib at the recommended Phase 2 dose of 200 mg orally twice daily (BID) and were evaluated on key safety and antitumor activity endpoints. These patients (n=24) were heavily pretreated, with a median of three prior lines of therapy (range 2-6), with 92% (22 out of 24 patients) having progressed on a prior KRAS(OFF) G12C inhibitor.​ Elironrasib demonstrated compelling antitumor activity, with a confirmed objective response rate of 42% (95% CI: 22-63) and a disease control rate of 79% (95% CI: 58-93). The median duration of response was 11.2 months (95% CI: 5.9-not estimable), and the median progression-free survival was 6.2 months (95% CI: 4.0-10.3). The median overall survival (OS) was not yet reached and 12-month OS rate was 62% (95% CI: 40-78).

These results are from RMC-6291-001, an ongoing multicenter, Phase 1 trial designed to evaluate elironrasib (RMC‑6291) monotherapy in patients with advanced KRAS G12C solid tumors.

Elironrasib is an innovative, mutant-selective inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately 12% of cases of NSCLC. Revolution Medicines is exploring elironrasib monotherapy and combinations in various treatment settings and continues work to prioritize among multiple options for advancing its development. In July 2025, elironrasib was granted Breakthrough Therapy Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.

NSCLC accounts for 80%-85% of all lung cancers, and most patients have advanced or metastatic disease at initial diagnosis.^1,2 KRAS mutations are found in nearly 30% of NSCLC cases, among which KRAS G12C is the most common.

Advancing RAS(ON) Inhibitor Platform Across Tumor Types
Jan Smith, Ph. D., chief scientific officer of Revolution Medicines will also highlight encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib and daraxonrasib during a plenary session at the start of the AACR-NCI-EORTC Symposium.

Several other presentations to be featured at the meeting demonstrate continued progress across Revolution Medicines’ RAS(ON) inhibitor portfolio, including:

• “Targeting the Oncogenic State of RAS with Tri-Complex Inhibitors”
• “RAS(ON) Inhibitor In-Pathway Combinations Maximize RAS Pathway Suppression in KRAS Mutant CRC Models”
• “Resistance Mechanisms to Monotherapy Daraxonrasib (RMC-6236) in RAS Mutant PDAC”
• “RASolve 301: A Phase 3 Study of Daraxonrasib (RMC-6236) vs. Docetaxel in RAS-Mutant NSCLC”

Further details and information on presentations can found on the AACR-NCI-EORTC Symposium website.

About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.³ 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.

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; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter 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 progression of clinical studies and findings from these studies, including the safety, tolerability and antitumor activity of the company’s candidates being studied and the durability of these results; the therapeutic potential of elironrasib; and the ability of the company to deliver a range of therapies or create new standards of care. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," 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’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 6, 2025, 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.com
investors@revmed.com

¹ American Cancer Society. What is Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed October 2025.
² National Cancer Institute. Non-Small Cell Lung Cancer Treatment. Available at: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq. Accessed October 2025.
³ American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed October 2025.

FAQ

What were elironrasib efficacy results for Revolution Medicines (RVMD) in KRAS G12C NSCLC as of Aug 4, 2025?

In the prior-OFF-inhibitor cohort (n=24) elironrasib showed a 42% confirmed ORR, 79% DCR, median DOR 11.2 months, and median PFS 6.2 months.

When and where will Revolution Medicines present the updated elironrasib data (RVMD)?

Data are highlighted in an oral presentation at the AACR-NCI-EORTC Symposium in Boston on Oct 23-25, 2025.

What is the recommended Phase 2 dose of elironrasib used in the reported RVMD trial?

Patients were treated at the recommended Phase 2 dose of 200 mg orally twice daily (BID).

Does elironrasib have any regulatory designations relevant to investors (RVMD)?

Elironrasib was granted Breakthrough Therapy Designation in July 2025 for certain previously treated KRAS G12C NSCLC patients not previously treated with a KRAS G12C inhibitor.

How mature are the survival data for elironrasib in the RVMD update?

Median overall survival is not yet reached; the 12-month OS rate reported was 62% with limited follow-up.