Revolution Medicines announces daraxonrasib's positive Phase 3 trial results in treating metastatic pancreatic adenocarcinoma, to be presented at ASCO.
Quiver AI Summary
Revolution Medicines, Inc. announced that results from its Phase 3 RASolute 302 clinical trial on daraxonrasib for metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented at the upcoming ASCO Annual Meeting. The trial revealed a significant overall survival benefit for patients treated with daraxonrasib compared to standard intravenous chemotherapy, meeting all primary and key secondary endpoints. The findings will be detailed in a plenary session led by Dr. Brian M. Wolpin from Dana-Farber Cancer Institute. The trial targeted patients with varying RAS mutations, and daraxonrasib has received Breakthrough Therapy Designation from the FDA for its potential effectiveness against this aggressive cancer. Additional abstracts related to daraxonrasib and treatment patterns in metastatic PDAC have also been accepted for publication.
Potential Positives
- Presentation of detailed results from the Phase 3 RASolute 302 clinical trial at the prestigious ASCO Annual Meeting highlights the company's commitment to transparency and scientific communication.
- Daraxonrasib demonstrated a statistically significant overall survival benefit over standard chemotherapy, marking a potential breakthrough in treatment for metastatic pancreatic ductal adenocarcinoma (PDAC).
- The FDA's granting of Breakthrough Therapy and Orphan Drug Designations for daraxonrasib underscores its potential significance in treating RAS-addicted cancers.
- The acceptance of additional Revolution Medicines-sponsored abstracts for online publication further establishes the company’s ongoing research contributions in oncology.
Potential Negatives
- The press release does not include data on the potential side effects or safety profile of daraxonrasib, which is critical information for stakeholders concerned about the drug's acceptability and marketability.
- Daraxonrasib is still an investigational drug and has not yet received regulatory approval, which could limit immediate market potential and investor confidence.
- The release highlights the severe nature of metastatic pancreatic ductal adenocarcinoma (PDAC), with a very low five-year survival rate, underscoring the challenges that the company faces in addressing this aggressive disease.
FAQ
What is the RASolute 302 clinical trial?
The RASolute 302 clinical trial evaluates the efficacy and safety of daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma patients.
When will the results of the RASolute 302 trial be presented?
The results will be presented at the ASCO Annual Meeting from May 29 to June 2, 2026, specifically on May 31.
What significant findings were reported about daraxonrasib?
Daraxonrasib demonstrated a statistically significant overall survival benefit and improved progression-free survival compared to standard chemotherapy.
Who is the presenting author of the daraxonrasib results?
The presenting author is Brian M. Wolpin, M.D., M.P.H. from the Dana-Farber Cancer Institute.
What types of cancers does daraxonrasib target?
Daraxonrasib targets cancers driven by RAS mutations, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$RVMD Insider Trading Activity
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Multiple analysts have issued price targets for $RVMD recently. We have seen 15 analysts offer price targets for $RVMD in the last 6 months, with a median target of $162.0.
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Full Release
REDWOOD CITY, Calif., April 21, 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 that detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented in a Plenary Session at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago.
Revolution Medicines recently reported an unprecedented overall survival (OS) benefit with daraxonrasib from the RASolute 302 clinical trial. These topline results showed that daraxonrasib taken once daily orally met all primary and key secondary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and OS compared with standard of care intravenous cytotoxic chemotherapy. The presentation will describe these findings, as well as additional analyses of efficacy and safety.
Presentation Details
Presenting Author:
Brian M. Wolpin, M.D., M.P.H., Dana-Farber Cancer Institute
Title:
Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Primary and final analysis from the phase 3 RASolute 302 study
Abstract:
LBA5
Session Name:
Plenary Session
Session Date:
May 31, 2026
Presentation Time:
3:21-3:33 PM CDT
Location:
McCormick Place, Hall B1
Additional Accepted Abstracts
The following additional Revolution Medicines–sponsored abstracts have been accepted for online publication:
- Systemic anticancer therapy in patients with de novo metastatic pancreatic adenocarcinoma: a real-world analysis (Abstract #e16383)
- Patient characteristics, treatment patterns, and survival in a metastatic pancreatic adenocarcinoma U.S. patient population (Abstract #e16379)
-
Safety and efficacy of daraxonrasib monotherapy as later-line (3L+) treatment for patients (pts) with metastatic pancreatic adenocarcinoma (PDAC) (Abstract #e15104)
About the RASolute 302 Clinical Trial
RASolute 302 ( NCT06625320 ) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of standard of care cytotoxic chemotherapy. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).
The primary endpoints of RASolute 302 are progression-free survival (PFS), as assessed by a Blinded Independent Central Review, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints include PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.
About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.
Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic 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 annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease. 1
Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations. 2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%. 3,4
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; 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-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.
Revolution Medicines Media & Investor Contact:
[email protected]
[email protected]
References
1
Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024.
CA Cancer J Clin.
2024;74(1):12-49. doi:10.3322/caac.21820
2
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.
3
Halbrook 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.2023.02.014
4
American Cancer Society. Survival Rates for Pancreatic Cancer. Available at:
https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html
. Accessed April 2026.