Kazia Offers Secondary OS Data to Build FDA Case for Glioblastoma Drug

Published: Jul 11, 2024 By Tristan Manalac

Brain cancer/iStock, wildpixel

Pictured: 3D illustration of a tumor on a brain/iStock, wildpixel

Kazia Therapeutics on Wednesday unveiled additional data from the Phase II/III GBM-AGILE study, picking out secondary efficacy signals as it eyes an FDA accelerated approval pathway for its investigational glioblastoma treatment paxalisib.

GBM-AGILE is a large global study designed to test several investigational glioblastoma treatments versus current standard of care. In the case of paxalisib, the study used chemotherapy with temozolomide for newly diagnosed patients and with lomustine for those with recurrent disease. The primary outcome of interest was overall survival (OS).

Paxalisib showed no signs of efficacy in the recurrent disease setting. Median OS in treated patients was 8.05 months, which was nearly two months shorter than the 9.69-month median OS in comparators treated with lomustine. The…
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