Particle.news
Download on the App Store

Daraxonrasib Doubles Survival in Phase 3 Trial of Treated Metastatic Pancreatic Cancer

An oral KRAS inhibitor that raised median survival to 13.2 months is now available through an FDA expanded access program pending formal review

Overview

  • The randomized Phase 3 RASolute-302 study reported median overall survival of 13.2 months with daraxonrasib versus about 6–6.7 months with standard chemotherapy and an approximately 60% lower risk of death.
  • Daraxonrasib is a once-daily oral drug that binds mutant KRAS to switch off cancer-driving signals in tumor cells and targets the mutations present in roughly 90% of pancreatic ductal adenocarcinomas.
  • Patients on the trial reported better pain control, appetite and weight while receiving daraxonrasib, even as about 96% experienced treatment-related adverse events, most commonly rash and gastrointestinal symptoms.
  • The FDA has cleared an expanded access program and Revolution Medicines is supplying the drug while preparing filings, a move that has generated heavy patient demand and operational strain at cancer centers handling case-by-case requests.
  • Revolution Medicines and investigators have launched global trials to test daraxonrasib earlier in treatment and researchers say the result validates KRAS as a druggable target with possible impact across other KRAS-driven cancers.