Kazia Unveils Final Data From Mid-Stage Paxalisib Data In Newly Diagnosed Glioblastoma Patients

Australia-based Kazia Therapeutics Limited KZIA announced final data from a Phase 2 study of paxalisib as first-line therapy in patients with glioblastoma.

• 60mg once daily was identified as the maximum tolerated dose (MTD) and selected for future studies. 
• Median overall survival (OS) in the intent-to-treat (ITT) population (n=30) was 15.7 months, which compares very favorably to 12.7 months historically reported with temozolomide in this patient group.
• Temozolomide is the only existing FDA-approved drug treatment for first-line treatment.
• Median progression-free survival (PFS) in the ITT population was 8.4 months, representing a substantial increment over the comparable figure of 5.3 months associated with temozolomide. 
• In the modified ITT (mITT) population, OS increased to 15.9 months.
• Kazia expects to receive a final clinical study report in 1Q CY2022.
• Last year, Kazia commenced participation in the GBM AGILE pivotal study. This global trial recruited its first patient to the paxalisib arm in January 2021, and recruitment is ongoing. 
• Kazia provisionally expects indicative data in CY2023. 
• Price Action: KZIA shares are down 9.29% at $9.08 during the market session on the last check Friday.