NeOnc’s Intranasal Delivery Shows Early Promise in Brain Cancer Trial
Event summary
- NeOnc’s NEO100 intranasal delivery achieved 48.9% six-month progression-free survival in a Phase 2a trial for recurrent IDH1-mutant high-grade glioma, surpassing the 20% benchmark (p=0.0047).
- Median overall survival was 26.09 months, with five of 24 patients remaining on treatment at data cutoff.
- No major toxicities reported; adverse events were predominantly low-grade.
- NeOnc plans to seek an FDA Type B meeting to discuss a potential registrational pathway.
The big picture
NeOnc’s NEO100 represents a novel approach to overcoming the blood-brain barrier, leveraging intranasal delivery to target IDH1-mutant gliomas. The Phase 2a results suggest a potential shift in brain cancer treatment, though the field remains challenging, as demonstrated by Novocure’s recent setback. If validated, this delivery method could expand beyond NEO100, influencing the development of other CNS-targeted therapies.
What we're watching
- Clinical Validation
- Whether NEO100’s signal can be reproduced in a larger, controlled study.
- Regulatory Pathway
- The outcome of NeOnc’s planned FDA Type B meeting and the evidence required for registration.
- Delivery Technology
- The broader adoption of intranasal delivery for brain cancer therapies if NEO100 succeeds.
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