Revolution Medicines to Present Updated Phase 1/2 Clinical Data for Daraxonrasib in First Line Metastatic Pancreatic Cancer Across Monotherapy and Combination Cohorts at the 2026 AACR Annual Meeting
Rhea-AI Summary
Revolution Medicines (Nasdaq: RVMD) will present updated Phase 1/2 data for daraxonrasib in first-line metastatic pancreatic ductal adenocarcinoma at AACR 2026.
As of Dec 1, 2025, daraxonrasib plus gemcitabine/nab-paclitaxel (n=40) showed a confirmed ORR 58% and 6-month PFS estimate 84%. Daraxonrasib monotherapy (n=40) showed ORR 47% and 6-month PFS 71%. Safety was described as manageable; median PFS and OS were not mature. The company says these data support ongoing Phase 3 evaluation, and the company recently reported RASolute 302 met primary and key secondary endpoints including PFS and OS.
Positive
- Combo ORR 58% (confirmed) in first-line RAS mutant metastatic PDAC
- Mono ORR 47% with one complete response reported
- 6-month PFS estimates: 84% (combo) and 71% (monotherapy)
- High disease control rate of 92% with monotherapy
- Phase 3 success: RASolute 302 reportedly met PFS and OS endpoints
Negative
- Grade ≥3 TRAEs: 33% anemia (combo), 38% overall in monotherapy cohort
- Discontinuation due to TRAEs: daraxonrasib 5% and GnP 15% (combo)
- Median PFS and OS not mature at data cutoff, limiting long-term interpretation
- Mean dose intensity reduced to 80–84%, indicating dose modifications
News Market Reaction – RVMD
On the day this news was published, RVMD declined 4.37%, reflecting a moderate negative market reaction. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $1.36B from the company's valuation, bringing the market cap to $29.87B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
RVMD fell 1.61% while key biotech peers like BPMC, VRNA, MDGL, MRNA, and ROIV showed modest gains between 0.06% and 0.9%, indicating stock-specific pressure rather than a sector-wide move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 13 | Phase 3 OS data | Positive | +41.4% | Pivotal RASolute 302 met all endpoints with strong overall survival benefit. |
| Apr 02 | Phase 3 trial start | Positive | +0.5% | RASolute 303 began treating first-line metastatic PDAC patients with daraxonrasib. |
| Jan 29 | First-in-human trial | Positive | +0.9% | First patient dosed in RMC-5127-001 targeting RAS G12V-mutated solid tumors. |
| Dec 18 | Phase 3 adjuvant start | Neutral | -1.0% | First patient randomized in RASolute 304 adjuvant PDAC trial after surgery. |
| Oct 27 | Orphan designation | Positive | +6.4% | FDA granted Orphan Drug Designation to daraxonrasib in pancreatic cancer. |
Clinical trial news has generally produced positive reactions, with an average move of 9.63% and 4 of 5 same-tag events showing aligned price gains.
Over the past six months, Revolution Medicines has steadily advanced daraxonrasib and its broader RAS(ON) pipeline. Key milestones included FDA Orphan Drug Designation in pancreatic cancer on Oct 27, 2025, first patient enrollment in the Phase 3 RASolute 304 adjuvant PDAC trial on Dec 18, 2025, and dosing of first patients with RMC-5127 in a first-in-human study. In April 2026, the pivotal Phase 3 RASolute 302 trial achieved a marked overall survival benefit, and the Phase 3 RASolute 303 first-line PDAC trial began treating patients, directly connecting to today’s updated Phase 1/2 frontline data.
Historical Comparison
Clinical-trial headlines for RVMD over the past year averaged moves of 9.63%, with most showing positive alignment, framing today’s frontline PDAC update within a history of impactful trial news.
Clinical news shows a progression from orphan designation to multiple Phase 3 trials and pivotal RASolute 302 survival data, while RASolute 303 and 304 expand daraxonrasib into first-line and adjuvant PDAC settings.
Market Pulse Summary
This announcement adds detailed Phase 1/2 frontline PDAC data for daraxonrasib, with notable ORR and 6‑month PFS/OS signals in both monotherapy and combination cohorts, alongside manageable safety. It complements earlier milestones such as Orphan Drug Designation and the pivotal RASolute 302 survival benefit. Investors may watch how these early results integrate with ongoing Phase 3 programs and subsequent readouts across PDAC settings and NSCLC.
Key Terms
progression-free survival medical
overall survival medical
objective response rate medical
disease control rate medical
phase 1/2 medical
phase 3 medical
orphan drug designation regulatory
AI-generated analysis. Not financial advice.
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 updated clinical data from two Phase 1/2 trials of daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Data from the daraxonrasib combination cohort will be presented in a late-breaking mini-symposium, and data from the monotherapy cohort will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting on April 21, 2026.
Findings from both trials support daraxonrasib’s continued evaluation in the first line setting, demonstrating manageable safety and tolerability profiles along with early signs of durable antitumor activity across monotherapy and combination approaches.
“Patients with metastatic pancreatic cancer continue to face challenging outcomes,” said Eileen M. O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center, and a key investigator for the RMC-6236-001 trial. “What I find notable about these datasets is the strength of antitumor activity observed with daraxonrasib across both monotherapy and combination therapy, along with manageable safety profiles. With longer follow up, these results further support the potential of a novel RAS-targeted therapy to meaningfully improve outcomes in frontline metastatic PDAC.”
“The activity observed with daraxonrasib in the first line setting, as both single-agent and combination therapy, represents a promising signal in this difficult-to-treat population,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “We believe these findings support continued evaluation of daraxonrasib in the ongoing Phase 3 RASolute 303 trial in patients with previously untreated metastatic PDAC.”
Daraxonrasib plus Chemotherapy as First Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma (Abstract #LB407)
RMC-GI-102 (NCT06445062) is a Phase 1/2 open-label, multicenter trial with multiple cohorts evaluating daraxonrasib-based combinations in patients with RAS mutant gastrointestinal tumors. The results to be presented at the AACR Annual Meeting focus on patients in the first line metastatic PDAC cohort treated with daraxonrasib plus gemcitabine and nab-paclitaxel (GnP).
As of a December 1, 2025 data cutoff, 40 patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 200 mg once daily in 28-day cycles plus GnP given on a Day 1 and Day 15 schedule. In these patients, daraxonrasib plus GnP had a manageable safety profile, and the safety profile observed for the combination regimen was consistent with the known safety findings of each respective agent. The most common Grade ≥3 treatment-related adverse events (TRAEs) were anemia (
Daraxonrasib plus GnP showed encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC. In patients who had at least 18 weeks of follow up prior to the data cutoff (n=40), the confirmed objective response rate (ORR) was
Daraxonrasib Monotherapy as First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma (Abstract #LB337)
RMC-6236-001 (NCT05379985) is a Phase 1/2 open-label, multicenter trial evaluating daraxonrasib monotherapy in patients with RAS mutant solid tumors.
As of a December 1, 2025 data cutoff, patients with previously untreated RAS mutant metastatic PDAC received daraxonrasib 300 mg daily in 21-day cycles. In these patients, the safety profile observed for daraxonrasib was generally consistent with the reported safety findings for daraxonrasib monotherapy in previously treated patients. All-grade TRAEs occurred in
Daraxonrasib demonstrated encouraging preliminary antitumor activity in patients with previously untreated RAS mutant metastatic PDAC, with an ORR of
Daraxonrasib is being evaluated in four global Phase 3 clinical trials: three in PDAC (two ongoing and one completed) and one in non-small cell lung cancer (NSCLC). The company recently announced that the pivotal Phase 3 RASolute 302 clinical trial in patients with previously treated metastatic pancreatic cancer met all primary and key secondary endpoints, including PFS and OS. In the trial, daraxonrasib demonstrated an unprecedented OS benefit in all enrolled patients (the intent to treat population), including those with tumors with and without (wild type) an identified RAS mutation.
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
About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its 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 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 daraxonrasib as a therapeutic option for patients with PDAC, including the ability of daraxonrasib to meaningfully improve outcomes in frontline metastatic PDAC.
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:
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
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.
