Kazia Therapeutics completes phase II trial of paxalisib in glioblastoma
Kazia chief executive officer Dr James Garner says the phase II trial has expanded the company’s understanding of paxalisib.
Kazia Therapeutics (ASX: KZA) is preparing to present the results of a phase II study evaluating its lead drug paxalisib in glioblastoma, which is the most aggressive form of brain cancer.
The phase II study is now complete, and Kazia has the report, with chief executive officer Dr James Garner saying the company was looking forward to sharing the 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,” Dr Garner said.
Key findings
The study involved 30 patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status – a genetic profile showing resistance to the only existing United States Food and Drug Administration approved first line treatment temozolomide.
A 60mg once a day dose of paxalisib was found to be the maximum tolerated dose for future studies.
The median overall survival rate in the intent-to-treat population (ITT) was 15.7 months, which Kazia says compares “very favourably” to the 12.7 months historically reported with temozolomide.
Meanwhile, median progression-free survival in the ITT population was 8.4 months – up from the 5.3 months associated with temozolomide.
Additionally, in the modified ITT group, which includes only patients evaluated for efficacy, the overall survival rate with paxalisib rose to 15.9 months.
Kazia noted the safety profile for the drug in the phase II trial was “highly consistent” with previous studies, with the most common side effects reported including hyperglycaemia, oral mucositis, and skin rash.
Ongoing research
The company is continuing to evaluate paxalisib in glioblastoma, with a GM AGILE trial approach underway.
GBM AGILE is a pivotal study in glioblastoma that begun recruiting for the paxalisib arm in January last year.
The pivotal study is run by an executive committee and a unique approach to clinical trials. It is a flexible and adaptable process that maintains several treatment arms – with the aim of identifying or disproving therapies faster.
Recruitment to the paxalisib arm in the study is continuing in the US and Canada, with the trial expected to open in Europe and China over the coming quarters.
Final data from this research is expected in the second half of next year.
Dr Garner said he hoped to see results from the GBM AGILE study confirm the positive signals from Kazia’s own phase II trial.