Revolution Medicines Presents Overall Survival Data for RASONQUE™ (daraxonrasib) Across Subgroups in Previously Treated Metastatic Pancreatic Cancer at ESMO 2026
- Expanding on the unprecedented final results previously reported from the Phase 3 RASolute 302 trial, the exploratory subgroup analyses showed RASONQUE consistently provided an overall survival benefit compared with chemotherapy across key subgroups, including patients with no identified tumor RAS mutation
- Findings presented as late-breaking abstract during Proffered Paper session
REDWOOD CITY, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, today announced that exploratory subgroup analyses from the Phase 3 RASolute 302 trial were presented as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The analyses showed that RASONQUE (daraxonrasib) consistently provided an overall survival (OS) benefit compared with chemotherapy across all evaluated RAS genotype subgroups among patients with previously treated metastatic pancreatic adenocarcinoma (PDAC), including those with no identified tumor RAS mutation. The OS benefit with RASONQUE was also maintained across preselected standard-of-care (SOC) chemotherapy regimens and prior treatment settings, including early metastatic recurrence following perioperative therapy.
“For people living with metastatic pancreatic cancer, progression after initial treatment can be devastating, with limited options and a poor prognosis,” said Zev A. Wainberg, M.D., Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program, RASolute 302 investigator and presenter of the data at ESMO. “The analysis presented at ESMO reinforces the unprecedented and statistically significant survival benefit of daraxonrasib observed in the overall study population of the RASolute 302 trial. The overall survival benefit was seen consistently across all evaluated tumor RAS profiles, underscoring the potential of daraxonrasib to benefit the broad population of patients with this devastating disease.”
In the RASolute 302 trial, patients were randomized to receive either RASONQUE 300 mg once daily (n=248) or investigator’s choice of standard chemotherapy (n=252). These exploratory subgroup analyses were derived from the prespecified primary analysis of RASolute 302, conducted at the February 10, 2026 data cutoff, which had a median follow-up of 8.5 months. In the previously reported primary analysis, median OS was 13.2 months with RASONQUE versus 6.7 months with chemotherapy (hazard ratio [HR] 0.40; 95% confidence interval [CI]: 0.30–0.53). For these exploratory analyses, across the RAS subgroups evaluated, the OS HR was 0.49 (95% CI: 0.33–0.74) for G12D mutations, 0.32 (95% CI: 0.19–0.54) for G12V mutations, 0.61 (95% CI: 0.29–1.30) for G12R mutations, 0.37 (95% CI: 0.09–1.44) for RAS Q61 mutations, and 0.43 (95% CI: 0.09–1.98) for tumors with no identified RAS mutation.
The analyses also showed a consistent OS benefit with RASONQUE across preselected SOC chemotherapy regimens, including gemcitabine plus nab-paclitaxel (GnP; HR 0.45; 95% CI: 0.32–0.65), pooled modified FOLFIRINOX/FOLFOX (HR 0.46; 95% CI: 0.23–0.95) and nanoliposomal irinotecan plus fluorouracil and leucovorin (NAL-IRI + 5-FU/LV; HR 0.32; 95% CI: 0.18–0.58).
The OS improvement was also seen among patients treated with RASONQUE compared with chemotherapy across prior treatment settings, including metastatic disease diagnosed less than six months after the last dose of neoadjuvant or adjuvant therapy (HR 0.36; 95% CI: 0.17–0.75) and one prior line of therapy for metastatic disease (HR 0.43; 95% CI: 0.32–0.58).
“These exploratory analyses across key subgroups from RASolute 302 reinforce RASONQUE as a potential new standard of care for eligible adults with metastatic pancreatic adenocarcinoma,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “They also support our broader clinical development program, which is evaluating targeted approaches across RAS variants and treatment settings with the goal of changing the treatment paradigm in RAS-addicted cancers where there is a significant unmet medical need. With RASONQUE approved in the United States, the European Medicines Agency’s Committee for Medicinal Products for Human Use recent positive opinion and regulatory reviews underway in other countries, we remain committed to expanding access to RASONQUE for eligible patients globally.”
The presentation (LBA82), titled “Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Additional subgroup analyses from the Phase 3 RASolute 302 study,” was delivered by Dr. Wainberg during the Proffered Paper 1: Gastrointestinal Tumour, Upper Digestive session on October 23, 2026, at the ESMO Congress in Madrid, Spain. The primary analysis from RASolute 302 was presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine.
About Pancreatic Adenocarcinoma
Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most challenging malignancies. RAS, a key growth control switch in human cells, is the main driver of pancreatic cancer, which is characterized by excessive RAS signaling. Each year, approximately 500,000 people globally are diagnosed with PDAC and it is the seventh leading cause of cancer-related deaths worldwide.1,2
Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited.3 For patients with metastatic PDAC, the five-year relative survival rate is approximately 3% worldwide.4
About the RASolute 302 Clinical Trial
RASolute 302 (NCT06625320) was a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of RASONQUE as a monotherapy in patients with previously treated metastatic pancreatic adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg RASONQUE once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represented standard of care across the globe. The trial enrolled patients with metastatic PDAC with RAS G12 mutations (such as G12D, G12V, and G12R), RAS G13 or Q61 mutations, as well as patients with no identified tumor RAS mutations.
The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included 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 RASONQUE™ (daraxonrasib)
RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor (TCI), approved by the U.S. FDA for the treatment of adult patients with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.5 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer (NSCLC). Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority.
U.S. INDICATION
RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
U.S. IMPORTANT SAFETY INFORMATION
RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.
U.S. WARNINGS AND PRECAUTIONS
Dermatologic and Soft Tissue Toxicity
RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3.
Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise patients to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.
Stomatitis and Oral Disorders
RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3.
Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.
Diarrhea
RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3.
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.
Gastrointestinal Perforation
RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointestinal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal.
Monitor patients for gastrointestinal perforation. Withhold RASONQUE if gastrointestinal perforation is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of gastrointestinal perforation are identified.
Interstitial Lung Disease (ILD)/Pneumonitis
RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with pancreatic adenocarcinoma, ILD/pneumonitis occurred in 2.4% of patients treated with RASONQUE, of which 0.9% were Grade 3, and one event was fatal.
Monitor patients for new or worsening pulmonary symptoms. Withhold RASONQUE if ILD/pneumonitis is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of ILD/pneumonitis are identified.
Embryo-Fetal Toxicity
Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.
ADVERSE REACTIONS
Serious adverse reactions occurred in 30% of patients treated with RASONQUE. Serious adverse reactions occurring in ≥ 2% of patients treated with RASONQUE were diarrhea (3.7%), pyrexia (3.3%), sepsis (2.9%), fatigue (2.1%), and hemorrhage (2.1%).
Adverse reactions leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including two patients who discontinued due to rash (0.8%).
The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
DRUG INTERACTIONS
- Strong CYP3A Inhibitors with P-gp Inhibition: Avoid concomitant use.
- Strong CYP3A Inhibitors without P-gp Inhibition: Reduce RASONQUE dosage.
- Moderate CYP3A Inhibitors with or without P-gp Inhibition: Reduce RASONQUE dosage.
- P-gp Inhibitors: Reduce RASONQUE dosage.
- Cyclosporine A: Avoid concomitant use.
- Strong CYP3A Inducers: Avoid concomitant use. Increase RASONQUE dosage if concomitant use cannot be avoided.
- Moderate CYP3A Inducers: Increase RASONQUE dosage.
- P-gp Substrates: Take at least 4 hours apart from RASONQUE.
PROPHYLACTIC MEASURES
When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the risk of dermatologic reactions:
- administer a topical corticosteroid (applied to the face and chest) and emollient creams
- advise patients to limit sun exposure and use broad-spectrum sunscreen (SPF 30 or higher)
- consider prophylactic oral antibiotics (e.g., doxycycline or minocycline)
Please see U.S. Full Prescribing Information for RASONQUE
About Revolution Medicines, Inc.
Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.
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 broad potential of RAS(ON) inhibition; the interpretation, significance and implications of the subgroup analyses and other data from the RASolute 302 trial; the potential of RASONQUE to become a standard of care or to change the treatment paradigm in pancreatic cancer or other RAS-addicted cancers; treatment practices; the company’s regulatory interactions and plans, including the timing and outcome of the European Commission’s decision following the CHMP positive opinion and of regulatory reviews in other jurisdictions; the commercialization, market acceptance and potential label expansion of RASONQUE; the company’s broader clinical development program; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of RASONQUE and the company 's product 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 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 5, 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 Contacts
Media
media@revmed.com
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References
1 Park W, Chawla A, O 'Reilly EM. Pancreatic cancer: A review. JAMA. 2021;326(9):851-862. doi:10.1001/jama.2021.13027
2 González-López J, Bauza ME, Pérez-Rojas J, et al. Pancreatic adenocarcinoma: Diagnosis by ultrasound-guided fine-needle aspiration—cyto-histological correlation and experience at a multidisciplinary tertiary reference center. Diagn Cytopathol. 2026;54(6):403-416. doi:10.1002/dc.70097
3 Rahib L, Coffin T, Kenner B. Factors driving pancreatic cancer survival rates. Pancreas. 2025;54(6):e530-e536. doi:10.1097/MPA.0000000000002489
4 Levine JM, Rompen IF, Franco JC, et al. The impact of metastatic sites on survival rates and predictors of extended survival in patients with metastatic pancreatic cancer. Pancreatology. 2024;24(6):887-893. doi:10.1016/j.pan.2024.06.004
5 RASONQUE (daraxonrasib) Prescribing Information. Redwood City, CA: Revolution Medicines, Inc.; August 2026.
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