Clinical TrialAug 13, 2026, 05:28 PM
NEONC Technologies NEO100-01 Phase 2a shows 26.1-month OS in glioma
AI Summary
NEONC Technologies announced positive top-line results from the Phase 2a portion of its NEO100-01 clinical trial for recurrent IDH1 mutant high-grade glioma. The study met its primary endpoint with a Progression-Free Survival at 6 months (PFS6) of 48.9% against a 20% benchmark. Patients treated with NEO100-01 demonstrated a median overall survival of 26.1 months, significantly extending life expectancy compared to the 6-9 months typically seen with current salvage therapies. The company plans to seek FDA guidance for a Phase 3 accelerated approval pathway.
Key Highlights
- NEO100-01 Phase 2a met primary endpoint for recurrent IDH1 mutant glioma.
- Median overall survival (OS) was 26.1 months vs. 6-9 months for salvage therapy.
- Progression-Free Survival at 6 months (PFS6) was 48.9% vs. 20% benchmark (p=0.0047).
- Overall survival at 12 months was 60.9%; over half of patients alive at 24 months.
- 66.7% of patients achieved disease control (partial response + stable disease).
- 55% of patients were long-term survivors (>1 year post-recurrence) across Phase 1/2.
- Company plans FDA meeting for Phase 3 accelerated approval pathway.
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