Particle.news
Download on the App Store

NEJM Data, FDA Access Boost Daraxonrasib After Phase 3 Survival Gain

NEJM paper underscores efficacy in a cancer with few options.

Overview

  • Early-phase results in 168 previously treated metastatic pancreatic cancer patients showed responses of about 29–35% at the 300 mg dose, disease control near 90%, and median progression-free survival around 8 months with overall survival roughly 13–16 months.
  • Side effects were common and included rash, diarrhea, mouth sores, nausea and fatigue, with about 30% of patients having severe events; dose holds or reductions were frequent, while permanent stops were rare.
  • Revolution Medicines said its randomized Phase 3 RASolute 302 trial improved overall survival versus standard chemotherapy, with full results set for presentation at the ASCO annual meeting on May 31.
  • The FDA cleared an expanded-access program for patients outside trials and has awarded Breakthrough and Orphan designations as well as selection for the Commissioner’s National Priority Voucher pilot program.
  • Daraxonrasib is an oral RAS(ON) inhibitor that pairs with cyclophilin A to block active RAS signaling, a broad tactic that could reach the more than 90% of pancreatic tumors driven by RAS mutations and may lessen reliance on infusion chemotherapy.