5 minOn April 13, Revolution Medicines (RevMed)—a late-stage clinical biotechnology company dedicated to developing targeted therapies for RAS-addicted cancers—announced unprecedented overall survival (OS) benefits from its pivotal global Phase III clinical trial (RASolute 302). The trial evaluated its core investigational drug, Daraxonrasib, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
Death Risk Slashed by 60%; Survival Doubled
RASolute 302 (NCT06625320) is a global, randomized, controlled Phase III registration trial. It was designed to evaluate the efficacy and safety of monotherapy Daraxonrasib compared to the investigator's choice of standard intravenous cytotoxic chemotherapy in patients with previously treated metastatic PDAC.
Data showed that once-daily oral administration of Daraxonrasib resulted in highly statistically significant and clinically meaningful improvements in survival. Within the intent-to-treat (ITT) population:
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Median Overall Survival (OS): Patients treated with Daraxonrasib saw survival extended to 13.2 months, compared to just 6.7 months for the standard chemotherapy control group—effectively doubling survival time.
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Risk Reduction: The risk of death was reduced by 60% ($HR = 0.40, p < 0.0001$).
Furthermore, the trial successfully met all primary and key secondary endpoints (including Progression-Free Survival (PFS)). Regarding safety, Daraxonrasib was well-tolerated with a manageable safety profile and no new safety signals observed. Based on these exceptional results from the first interim analysis, all PFS and OS endpoint data have been declared final.
About Daraxonrasib
Pancreatic cancer is the most "RAS-addicted" of all major cancers, with over 90% of patients carrying RAS protein mutations. Daraxonrasib is an oral, non-covalent, multi-selective RAS(ON) inhibitor. It precisely inhibits the interaction between wild-type and mutant RAS(ON) proteins and their downstream effectors, effectively blocking RAS signaling.
Notably, the RASolute 302 trial enrolled patients with a broad range of RAS variants (including G12D, G12V, G12R, and other G12 mutations) as well as patients with no detected RAS mutations (wild-type). This underscores Daraxonrasib’s potential to address an extremely wide and complex array of oncogenic drivers.
With this broad yet precise targeting mechanism, Daraxonrasib is being developed not only for PDAC but also for non-small cell lung cancer (NSCLC) and colorectal cancer. The drug is currently in four global Phase III registration trials (three for PDAC and one for NSCLC).
The U.S. FDA previously granted Daraxonrasib Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) for previously treated metastatic PDAC with G12 mutations. Additionally, the drug was selected for the FDA Commissioner’s "National Priority Review" pilot program, which will further accelerate the review process.
Next Steps for the Company
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Accelerated NDA Submission: RevMed plans to submit the data from this trial as the core of a New Drug Application (NDA) to the U.S. FDA and other global regulatory agencies in the coming months. Supported by the "National Priority Review," the company aims to bring this transformative therapy to market as quickly as possible.
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Publication of Results: Detailed data from the RASolute 302 trial will be presented to the global scientific and clinical community at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
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Pipeline Expansion: The success of this clinical trial validates the company’s pioneering approach to targeting common RAS-dependent cancers by inhibiting RAS(ON). Leveraging 15 years of expertise in RAS biology (including the foundation laid by the 2018 acquisition of Warp Drive Bio), RevMed will continue to accelerate three other differentiated clinical-stage candidates to consolidate its position as an engine of oncology innovation.
