Clinical TrialAug 12, 2026, 08:37 AM
NeOnc Technologies NEO100 Phase 2a PFS-6 48.9%, OS 26.09 Months
AI Summary
NeOnc Technologies Holdings, Inc. announced positive topline results from the Phase 2a portion of its NEO100-01 study for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint with a six-month progression-free survival (PFS-6) of 48.9%, significantly exceeding the pre-specified 20% benchmark for standard of care. The drug demonstrated encouraging survival outcomes, including a median overall survival of 26.09 months from recurrence, and was well-tolerated with no major toxicities. The company plans to engage with the FDA to discuss a registrational study path.
Key Highlights
- NEO100 Phase 2a met primary endpoint: 6-month progression-free survival of 48.9% (p=0.0047).
- Median overall survival was 26.09 months from recurrence, compared to 6-9 month benchmark.
- Overall survival rates: 86.7% at 6 months, 60.9% at 12 months, and 54.1% at 24 months.
- Five of 24 patients remain on treatment, with one partial response ongoing beyond 114 days.
- No major toxicities reported across the cohort; adverse events were predominantly low-grade.
- Company will request a Type B meeting with the FDA to align on a registrational development path.
- Proposed Phase 3 design includes randomized NEO100 vs. lomustine with overall survival as primary endpoint.
Price Impact
More from NTHI