Revolution Medicines Announces Publication in New England Journal of Medicine of Phase 1/2 Clinical Data on Daraxonrasib in Pancreatic Cancer
Rhea-AI Summary
Revolution Medicines (NASDAQ: RVMD) announced that the New England Journal of Medicine published Phase 1/2 data for daraxonrasib in previously treated metastatic RAS‑mutant pancreatic ductal adenocarcinoma (PDAC). The published results supported initiation of the global Phase 3 registrational trial RASolute 302.
According to the company, Phase 1/2 data showed clinical antitumor activity, durable responses, and an acceptable safety profile; the company also announced positive topline RASolute 302 results reporting an overall survival benefit versus standard cytotoxic chemotherapy.
Positive
- NEJM publication of Phase 1/2 PDAC data
- Phase 1/2 data supported start of global Phase 3 RASolute 302
- Company-reported RASolute 302 topline announced an overall survival benefit versus chemotherapy
Negative
- Phase 1/2 cohort was single-arm, limiting direct comparative evidence prior to Phase 3
News Market Reaction – RVMD
In the May 7 session, RVMD declined 5.67%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 29 | First-in-human trial | Positive | +0.9% | First patient dosed in RMC-5127-001 RAS(ON) G12V-selective inhibitor trial. |
| Apr 02 | Phase 3 initiation | Positive | +0.5% | Start of RASolute 303 Phase 3 trial for first-line metastatic PDAC. |
| Apr 13 | Phase 3 topline | Positive | +41.4% | RASolute 302 met endpoints with strong overall survival vs chemotherapy. |
| Apr 21 | Phase 1/2 update | Positive | -4.4% | Updated Phase 1/2 daraxonrasib data in first-line metastatic PDAC at AACR. |
| Apr 21 | ASCO plenary plan | Positive | +1.8% | Announcement of planned ASCO plenary presentation for RASolute 302 results. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial announcements have generally produced positive price reactions for RVMD, especially the pivotal RASolute 302 topline, with only one notable divergence on updated Phase 1/2 data.
Recent RVMD news has centered on advancing its RAS(ON) pipeline, particularly daraxonrasib in pancreatic cancer. Since Jan 29, 2026, the company has moved from first-in-human studies like RMC-5127 to multiple global Phase 3 programs, including RASolute 302 and 303. The Apr 13 RASolute 302 topline showing strong survival benefit drove a large positive reaction, while later conference-focused data updates had more modest or mixed impacts. Today’s NEJM publication reinforces the same clinical narrative by formalizing earlier Phase 1/2 findings.
Key Terms
phase 1/2 medical
phase 3 medical
overall survival medical
cytotoxic chemotherapy medical
monotherapy medical
open-label medical
multicenter medical
non-small cell lung cancer medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data contributed to the scientific and clinical rationale for RASolute 302, a pivotal Phase 3 trial in second line treatment of patients with metastatic pancreatic cancer
REDWOOD CITY, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that The New England Journal of Medicine (NEJM) has published a report describing data from the Phase 1/2 clinical trial evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma (PDAC). The promising Phase 1/2 findings provided important insights supporting initiation of the company’s global, randomized Phase 3 registrational trial, RASolute 302. Revolution Medicines recently announced positive topline results from the RASolute 302 clinical trial showing an unprecedented overall survival benefit with daraxonrasib compared to standard of care cytotoxic chemotherapy, consistent with the Phase 1/2 single-arm observations.
“RAS mutations are a central driver of disease across multiple solid tumors, including particularly pancreatic ductal adenocarcinoma. There is significant room for improvement in outcomes over current standard of care -- cytotoxic chemotherapies that are not targeted to these underlying RAS cancer drivers,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile, in patients with previously treated metastatic RAS mutant PDAC. These results, along with those from our Phase 3 trial, RASolute 302, strengthen our confidence in daraxonrasib’s potential to establish an important new treatment option for patients with pancreatic cancer and other RAS-addicted cancers.”
The data published in NEJM reflect outcomes in the PDAC cohort from the RMC-6236-001 trial (NCT05379985), an open-label, multicenter Phase 1/2 trial evaluating daraxonrasib monotherapy in patients previously treated for metastatic solid tumors harboring RAS mutations.
In addition to RASolute 302, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC in earlier treatment lines and those with metastatic RAS mutant non-small cell lung cancer.
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 are 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
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 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 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; dosing and enrollment in the company’s clinical trials; the company’s expectations regarding from clinical trials; and the potential of daraxonrasib to estalish a new treatment option for patients with pancreatic cancer or other RAS-addicted cancers. 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 November 5, 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
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1 Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
2Lee 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.
3Halbrook 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
4American Cancer Society. Survival Rates for Pancreatic Cancer. Available at: https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 2026.
