RVMD
Live News • Jun 08
Revolution Medicines Reports Daraxonrasib More Than Doubles Survival in Advanced Pancreatic Cancer Trial Revolution Medicines reported that its Phase 3 RASolute 302 trial of daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma more than doubled median overall survival to 13.2 months versus 6.7 months for standard chemotherapy.
The trial met all primary and key secondary endpoints, including progression-free survival and overall response rate, and was associated with manageable safety along with better pain control and quality of life.
The company has begun a rolling New Drug Application filing with the FDA, is planning global regulatory submissions, and has an FDA-authorized expanded access program in place for daraxonrasib.
The strength and breadth of the Phase 3 data positions daraxonrasib as a potential first commercial product for Revolution Medicines. The company is currently a clinical-stage biotech with no revenue and a pipeline focused on RAS(ON) targeted therapies.
Investors should weigh the upside of a possible first approval and broader RAS franchise against typical biotech risks, including regulatory review outcomes, time to any potential commercialization, and the funding needs of a company that does not yet generate product revenue. Announcement • Jun 03
Revolution Medicines Presents Unprecedented Results from Pivotal Phase 3 Rasolute 302 Clinical Trial of Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer Revolution Medicines, Inc. announced detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib, an oral RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The results will be presented during a late-breaking Plenary Session (LBA5) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and were published in The New England Journal of Medicine. RAS, a key growth control switch in human cells, is the primary oncogenic driver of PDAC, a disease that is typically characterized by excessive RAS(ON) signaling in tumors with or without a mutant allele of RAS. Daraxonrasib is the first investigational agent in a novel class of RAS(ON) multi-selective inhibitors designed to address a diverse and broad spectrum of RAS variants. In the randomized Phase 3 RASolute 302 trial, once-daily oral daraxonrasib demonstrated unprecedented improvements in overall survival (OS) and progression-free survival (PFS) compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. All primary and key secondary endpoints of the trial were met. Daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. The trial enrolled 500 patients with previously treated metastatic PDAC, randomized to receive once-daily oral daraxonrasib (n=248) or investigator’s choice of four different cytotoxic chemotherapy regimens (n=252), which represent standard of care across the globe. At the February 10, 2026 data cutoff, median follow-up was 8.5 months (range, 3.2–15.9). The trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements versus chemotherapy in both the RAS G12 mutant population (daraxonrasib n=228; chemotherapy n=231) and the overall, or intent-to-treat (ITT), population, which included patients with or without an identified tumor RAS mutation. Daraxonrasib resulted in a 60% reduction in the risk of death in both the RAS G12 and ITT populations. In the RAS G12 population, daraxonrasib demonstrated a hazard ratio (HR) of 0.40 (95% confidence interval [CI]: 0.30–0.54). 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. 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%. 
