Ann: Kazia releases final data from P2 paxalisib trial, page-3

3 December 2021
KAZIA ANNOUNCES POSITIVE FINAL DATA FROM PHASE II CLINICAL STUDY
OF PAXALISIB IN NEWLY DIAGNOSED GLIOBLASTOMA
Sydney, 3 December 2021 – Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an
oncology-focused drug development company, is pleased to announce positive final data
from a phase II clinical study of paxalisib as first line therapy in patients with glioblastoma
(NCT03522298). The results confirm the previously reported safety and efficacy profile with
paxalisib in this high unmet need disease.
Key Points
• The study recruited 30 patients with newly diagnosed glioblastoma and
unmethylated MGMT promotor status, a genetic profile which 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 (11.1 – 19.1), which compares very favourably to 12.7 months historically
reported with temozolomide in this patient group.1
• Median progression-free survival (PFS) in the ITT 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 ITT (mITT) population (n=27), which includes only those patients
evaluable for efficacy, OS increased to 15.9 months (12.8 – 19.1).
• The safety profile of paxalisib was highly consistent with previous clinical studies:
hyperglycaemia, oral mucositis, and skin rash were among the most common drugrelated toxicities.
• Kazia expects to receive a final clinical study report in 1Q CY2022 and intends to seek
publication of these data in a peer-reviewed scientific journal thereafter.