Overview
- The NEJM study, published Wednesday, reports that the oral RAS(ON) inhibitor showed meaningful activity in previously treated metastatic pancreatic cancer, with response rates near 30–35% at the 300 mg dose and median progression-free survival around 8 months.
- Survival in phase 1/2 exceeded historical second-line chemotherapy, with overall survival of about 13–16 months in key cohorts where past benchmarks are roughly 5–7 months.
- Safety required active management as nearly all patients had treatment-related side effects and about 30% had severe events, most often rash, diarrhea, and mouth or throat inflammation, leading to dose pauses or reductions for some patients.
- The FDA recently permitted an expanded access program for daraxonrasib, and the drug holds Breakthrough Therapy and Orphan Drug designations for previously treated metastatic disease.
- Revolution Medicines reported positive topline phase 3 results with an overall survival advantage versus standard chemotherapy, and investigators will present the final analysis at ASCO on May 31, as the field weighs a daily pill that targets active RAS in a cancer where more than 90% of tumors carry RAS mutations.