NeOnc Technologies announced positive topline results from the Phase 2a study of its lead candidate, NEO100, for patients with recurrent high-grade IDH1-mutant glioma. The study successfully met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival and a favorable safety profile for the intranasally administered therapy.
Key Details
- Primary Endpoint Met: The study achieved a six-month progression-free survival (PFS-6) rate of 48.9%, significantly exceeding the pre-specified 20% benchmark for standard of care (p = 0.0047).
- Survival Outcomes: The trial showed a median overall survival of 26.09 months, with 86.7% of patients alive at six months. Five of the 24 patients remain on treatment.
- Safety & Next Steps: NEO100 was well-tolerated with no major toxicities reported. The company plans to request a Type B meeting with the FDA to discuss a registrational development path for the treatment.