Kazia Therapeutics says phase 2 study of paxalisib completed

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Oncology-focused drug development company Kazia Therapeutics (ASX:KZA) has announced that its phase 2 study of paxalisib in glioblastoma (NCT03522298) has been successfully completed.

The company said it has received a final clinical study report and abstract summarising the results of the study. it has been accepted for presentation at an upcoming international clinical oncology conference.

The study recruited 30 patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, a genetic profile that confers primary resistance to temozolomide, the only existing FDA-approved drug treatment for first-line treatment.

The company said median overall survival in the intent-to-treat population (n=30) was 15.7 months (11.1 – 19.1), which compares very favourably to 12.7 months historically reported with temozolomide in this patient group.

Kazia CEO Dr James Garner said, “We are very pleased to have successfully completed this last step in the phase II study of paxalisib, and we look forward to sharing detailed data with clinicians and investors over coming months.

"This study has greatly expanded our understanding of paxalisib, and the insights it has provided have informed all our subsequent work with the drug. We are grateful to the clinicians and patients that have participated. Paxalisib is now the subject of an ongoing pivotal study in glioblastoma, GBM AGILE, and we hope to see results from that study confirm the very positive signals seen in this phase II trial.”

Dr Patrick Wen, the principal investigator at Dana-Farber Cancer Institute, added, “we look forward to presenting the final data from this phase II study and continuing our investigations in the multi-drug GBM AGILE study. Glioblastoma is a devastating diagnosis and we are encouraged by the prospect of providing new hope to this patient community."