REDWOOD CITY — Revolution Medicines, an oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, 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.
