NeOnc reports Phase 2a NEO100-01 met primary endpoint in recurrent IDH1 mutant glioma
In an August 12, 2026 investor call, NeOnc said NEO100 hit its PFS6 benchmark and reported a 26.1-month median overall survival in recurrent high-grade glioma patients.
NeOnc Technologies Holdings hosted an investor conference call on August 12, 2026 to discuss results from the Phase 2a portion of NEO100-011, a trial in recurrent IDH1 mutant high-grade glioma.
Company executives said the trial achieved a PFS6 of 48.9% versus the 20% benchmark1, with an intent-to-treat population that totaled 24 patients, of whom 21 were recurrent Grade IV and three were Grade III1. The company said this result was highly significant compared to the 20% benchmark, with a P value of 0.00471.
On secondary endpoints, NeOnc reported a median overall survival of 26.09 months from recurrence, compared with a historical benchmark of six to nine months1. The company also said overall survival durability was seen across six to 24 months, with six-month OS at 86.7%, 12-month OS at 60.9%, and over half of patients still alive at 24 months1. For the objective response rate endpoint, the company said the objective response rate according to RANO 2.0 criteria was 8.3%1.
On disease control, NeOnc said 66.7% of the 24 patients had disease control, including partial response and stable disease1.
Looking ahead, the company said its next step is to meet with the FDA to discuss a proposed Phase 3 design randomized against approved lomustine, seeking an accelerated approval pathway with an interim analysis and final overall survival as the registrational endpoint1.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.