Daraxonrasib has shown promising results in patients with previously treated RAS-mutated pancreatic ductal adenocarcinoma (PDAC), according to a Phase 1/2 study published in the New England Journal of Medicine. The drug works by blocking the active “ON” state of RAS proteins, helping stop cancer growth signals.
In second-line treatment, patients with RAS G12 mutations achieved a 35% response rate and median overall survival of 13.1 months. Across all RAS mutations, the response rate was 29%, with a disease control rate of 95%. Most side effects, including rash and diarrhea, were mild, and no patients stopped treatment because of toxicity.
New Phase 3 RASolute 302 results showed daraxonrasib nearly doubled survival compared with chemotherapy alone, improving overall survival from 6.7 months to 13.2 months. The FDA has granted Breakthrough Therapy and Orphan Drug designations, and an expanded access program is now available.