Kazia Therapeutics is set to engage with the U.S. Food and Drug Administration (FDA) in a Type C meeting this December to explore potential routes for the registration of paxalisib in treating newly diagnosed glioblastoma multiforme (GBM). Paxalisib, a brain-penetrant PI3K/mTOR inhibitor, has shown promise in clinical trials, positioning it as a potential new therapeutic option for this aggressive brain cancer.
The upcoming meeting is prompted by results from the Phase II/III GBM-AGILE clinical trial. The trial demonstrated that newly diagnosed, unmethylated GBM patients treated with paxalisib experienced a clinically meaningful improvement in overall survival in a pre-specified secondary analysis. Full data, including secondary endpoints from the paxalisib arm of the GBM-AGILE study, are slated for presentation at an upcoming scientific meeting.
Paxalisib's Clinical Background
Paxalisib has been granted both Orphan Drug Designation and Fast Track Designation by the FDA for glioblastoma in patients with unmethylated MGMT promoter status, specifically following radiation plus temozolomide therapy. These designations underscore the FDA's recognition of paxalisib's potential to address an unmet need in a serious condition.
Corporate Updates and Presentations
Kazia Therapeutics has updated its corporate presentation to include preliminary data from the GBM AGILE Phase II/III clinical trial, which evaluated paxalisib against the standard of care for glioblastoma. The updated presentation is available on the company's website.
Kazia Therapeutics is actively participating in medical conferences. The company plans to attend the Society for Neuro-Oncology 29th Annual Meeting and Education Day in November 2024 and the San Antonio Breast Cancer Symposium in December 2024. These events provide opportunities to engage with key stakeholders and share the company's vision for innovative cancer treatments.
About Kazia Therapeutics
Kazia Therapeutics Limited is an oncology-focused drug development company based in Sydney, Australia. Their lead program, paxalisib, is under development for multiple forms of brain cancer. Kazia also has EVT801, a small-molecule inhibitor of VEGFR3, in its pipeline.
