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NeOnc Technologies Holdings announced top-line results from the Phase 2a trial of NEO100-01 in recurrent IDH1 mutant…
NTHINeonc Technologies Holdings, Inc.
NeOnc Technologies Holdings announced top-line results from the Phase 2a trial of NEO100-01 in recurrent IDH1 mutant high-grade glioma. The study met its primary endpoint, achieving a progression-free survival at six months (PFS6) of 48.9%, significantly exceeding the 20% benchmark with a p-value of 0.0047. Median overall survival was 26.1 months from recurrence, compared to a historical salvage therapy benchmark of six to nine months. The trial enrolled 24 patients, predominantly those with recurrent Grade IV disease. NeOnc plans to present these results to the FDA and pursue accelerated approval via a randomized Phase 3 trial against lomustine. NeOnc Technologies Holdings is a clinical-stage biopharmaceutical company developing novel intranasal therapies for brain cancer.