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(RTTNews) - Kazia Therapeutics (KZIA) reported results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care for patients with glioblastoma. The company said the GBM AGILE trial data showed clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma.

Kazia CEO, John Friend said, "We are excited to have shown a 3.8 month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard of care arm. Having comparable Overall Survival data across two independent studies is a compelling outcome in this difficult to treat glioblastoma population."

Based on the totality of data available from all completed paxalisib clinical studies in newly diagnosed unmethylated GBM patients, the company will request a meeting with the FDA to discuss the results and determine if a potential path to accelerated approval is appropriate for paxalisib.

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