Kazia Therapeutics Concludes Mid-Stage Paxalisib Study In Brain Cancer

Kazia Therapeutics Limited 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.

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