Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA), a cancer-focused drug development company based in Sydney, has released final data from its Phase 2 clinical study of the drug paxalisib – a first-line therapy in patients with glioblastoma.
The company reports that these results confirm the asset’s previously reported safety and efficacy markers, and the company has high hopes that this signals a breakthrough in the treatment of a complex disease of “high unmet need".
Shares have been as much as 6.72% higher in early trading to A$1.48 while the market cap pre-open was approximately A$183.6 million.
About the study
The study recruited 30 patients with newly diagnosed glioblastoma. The patients also shared a genetic profile that confers primary resistance to temozolomide, the only existing FDA-approved drug treatment for first line treatment of their condition.
Patients were given 60mg once daily, the previously identified maximum tolerated dose (MTD).
The median overall survival in the intent-to-treat population was 15.7 months (11.1–19.1), which compares favourably to the 12.7 months historically reported following temozolomide treatment in this patient group.
Median progression-free survival in this population was 8.4 months (6.6–10.2), representing a substantial increment over the comparable figure of 5.3 months associated with temozolomide.
In the modified intent-to-treat population (27 patients), which included only those patients evaluable for efficacy, overall survival increased to 15.9 months (12.8–19.1).
Safety of paxalisib
The safety profile of paxalisib was highly consistent with previous clinical studies. Hyperglycaemia, oral mucositis and skin rash were among the most common drug-related toxicities.
Kazia expects to receive a final clinical study report in the first quarter of the coming year and will then seek publication of these findings in a peer-reviewed scientific journal.