Benzinga | Jan 7, 2021 05:09AM EST

Kaizia Reported GBM AGILE Pivotal Study (NCT03970447) has Commenced Recruitment to the Paxalisib Arm

Kazia Therapeutics Limited (NASDAQ:KZIA) is pleased to announce that the GBM AGILE pivotal study (NCT03970447) has commenced recruitment to the paxalisib arm. Key Points GBM AGILE is an international adaptive, multi-drug study, designed to expedite the development of new therapies for glioblastoma Kazia executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) in October 2020 to bring paxalisib into GBM AGILE Lead investigators for the paxalisib arm are Professor Ingo Mellinghoff (Memorial Sloan Kettering Cancer Center) and Dr Eudocia Q Lee (Dana-Farber Cancer Institute) Positive data from GBM AGILE is expected to support registration of paxalisib in the US and other key markets Kazia CEO, Dr James Garner, commented, "we are delighted to have recruitment underway, and this marks an important milestone for Kazia as we begin the new year. The GBM AGILE study has secured the support of leading clinicians in the glioblastoma field, and has increasingly won the confidence of regulators and industry participants, so we are excited to be a part of it. If the data from GBM AGILE is positive, we expect it to provide a basis for registration in glioblastoma, and it therefore represents an important step towards commercialisation of the drug. Clinical Trial Design The paxalisib arm of GBM AGILE will recruit newly diagnosed patients with the unmethylated MGMT promotor, a genetic marker that denotes near-total resistance to temozolomide, the existing FDA-approved standard of care. In addition, the study will recruit recurrent patients who have progressed despite treatment with temozolomide. The adaptive design allows GBM AGILE to balance between these two patient groups according to emerging data, so it is possible for paxalisib to emerge successful in one or both populations. The primary endpoint of GBM AGILE is overall survival, which is considered the gold standard for the evaluation of new cancer therapies, and which is the preferred approval endpoint for regulators such as the US FDA.