NeOnc Technologies Holdings announced positive top-line results from the Phase 2a portion of its NEO100-01 clinical trial for patients with recurrent IDH1 mutant high-grade glioma. The trial met its primary endpoint, demonstrating a statistically significant improvement in survival rates compared to historical benchmarks for this difficult-to-treat brain cancer.
Key Details
- Primary Endpoint Met: The trial achieved a Progression-Free Survival at 6 months (PFS6) of 48.9%, significantly exceeding the pre-specified 20% benchmark (p=0.0047).
- Improved Overall Survival: Patients showed a median Overall Survival (OS) of 26.1 months from recurrence. This represents a 4-5x improvement over the historical benchmark of 6-9 months for current salvage therapies.
- Next Steps: The company plans to meet with the FDA to discuss a proposed Phase 3 trial design and to seek guidance on an accelerated approval pathway for NEO100.