- Kazia Therapeutics Limited (NASDAQ:KZIA) has completed a Phase 2 study of paxalisib in glioblastoma.
- Kazia has received a final clinical study report, and an abstract summarizing the study results has been accepted for presentation at an upcoming international clinical oncology conference.
- The study recruited 30 patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, a genetic profile that confers primary resistance to temozolomide, the only existing FDA-approved drug treatment for first-line treatment.
- 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.
- 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 (n=27), which includes only those patients evaluable for efficacy, OS increased to 15.9 months.
- 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.
- The GBM AGILE pivotal study in glioblastoma commenced recruitment to the paxalisib arm in January 2021.
- Recruitment to the paxalisib arm is ongoing in the U.S. and Canada.
- The study is expected to open in Europe and China during Q2 or Q3 of CY2022. Final data from the study is expected in 2H CY 2023
- Price Action: KZIA shares are up 2.37% at $7.79 on press time Thursday.
