NeOnc Technologies reported Phase 2a results for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma, saying the program met its primary endpoint for six-month progression-free survival. The company cited a PFS-6 of 48.9% versus a pre-specified 20% benchmark, with a reported p-value of 0.0047, in a 24-patient open-label cohort. NeOnc also reported median overall survival of 26.09 months and survival rates of 86.7% at six months, 60.9% at 12 months, and 54.1% at 24 months. The company highlighted that multiple patients remained on treatment, including at least one progression-free for roughly 19 months. NeOnc said it plans to request a Type B meeting with the FDA to discuss a potential registrational path, translating early signal into regulatory planning for a broader development strategy.
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