- Kazia Therapeutics (KZA) opens the trading day green after reporting positive final results from a second-phase clinical study of its paxalisib drug for brain tumours
- The 30-patient trial confirmed some previously-reported safety and efficacy results for paxalisib in treating glioblastoma
- Kazia says it identified a 60-milligram dose, administered once daily, as the maximum tolerated dose for the drug
- Meanwhile, overall survival (OS) for the study averaged 15.7 months, which compares favourably with results from conventional treatments of 12.7 months for this patient group
- Shares in Kazia Therapeutics were up 4.33 per cent to $1.44 at 10:43 am AEDT
Kazia Therapeutics (KZA) has opened the trading day green after reporting positive final results from a second-phase clinical study of its paxalisib drug for brain tumours.
The company today told investors the trial confirmed previously-reported safety and efficacy results for the drug in treating patients with glioblastoma — a malignant tumour on the brain or spine that is almost always fatal.
As part of the study, Kazia recruited 30 patients with newly-diagnosed glioblastoma and ‘unmethylated MGMT promotor status’. This is a genetic profile that typically indicates resistance to temozolomide, the only existing approved first-line drug treatment for this aggressive brain cancer.
The primary goal of the study was to evaluate the safety and tolerability of paxalisib and determine an appropriate maximum dosage for the drug. Other conventional trial objectives, like survivability, were secondary endpoints for this second-phase study.
Kazia said the safety profile of the drug was consistent with previous clinical studies, with hyperglycaemia, oral mucositis, and skin rash among the most common side-effects of the drug. The company said it identified a 60-milligram dose, administered once daily, as the maximum tolerated dose for the drug.
Meanwhile, overall survival (OS) of the 30-patient cohort was an average of 15.7 months. Kazia said this compared favourably with historical temozolomide results for this patient group of 12.7 months.
Kazia CEO James Garner said the company was “delighted” to report the final data from the phase II trial.
“The data continue to demonstrate a clear efficacy signal and favourable safety profile, suggesting a meaningful advantage over temozolomide, the existing standard of care, and validating our decision last year to join the GBM AGILE pivotal study,” Dr Garner said.
“We have gleaned invaluable insights from this trial, and we are tremendously grateful to the investigators and to the patients who participated.”
Kazia joined the GBM Agile study in October last year.
Dr Garner said looking ahead, the company was working to “confirm and quantify” the benefit of paxalisib in glioblastoma patients as it moves towards a potential marketing authorisation.
“This indeed is the focus of our participation in GBM AGILE, which commenced recruiting to the paxalisib arm in January 2021,” Dr Garner said.
Recruitment for the GBM trial is still ongoing, with indicative data from the study currently slated for sometime in 2023.
Meanwhile, Kazia is busy undertaking seven other studies of paxalisib in other forms of brain cancer or cancer that has metastasized in the brain.
The company previously said it expected to complete at least two more data read-outs from these studies before the end of 2021, but Kazia today said this is now looking more like early 2022.
Shares in Kazia Therapeutics were up 4.33 per cent to $1.44 at 10:43 am AEDT. The company has a $191 million market cap.