Overview
- The randomized phase‑III trial, which reported results Monday, enrolled about 500 previously treated patients and found median overall survival of 13.2 months with Daraxonrasib versus 6.6 months with standard chemotherapy in the RAS‑G12 subgroup.
- The drug also extended median progression‑free survival to 7.3 months versus 3.5 months with chemotherapy and produced tumor shrinkage in a higher share of patients.
- Daraxonrasib is an oral RAS‑ON inhibitor that targets mutationally activated RAS proteins, a driver present in roughly 90 percent of pancreatic tumors, making the drug relevant to most patients with this cancer.
- Trial data showed a more favorable tolerability profile with fewer severe adverse events and far fewer treatment discontinuations (severe AEs 61.8% versus 69.6%; discontinuations 1.2% versus 11.2%), and patients reported better quality‑of‑life signals.
- The FDA has granted Breakthrough Therapy and Orphan Drug designations and allowed controlled pre‑approval access in the U.S., the manufacturer is preparing global regulatory filings, Europe remains pending approval, and researchers plan tests of the drug in other RAS‑driven cancers.