Ann: Kazia's paxalisib SNO data, page-4

Sydney, 18 November 2020 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an
Australian oncology-focused biotechnology company, is pleased to share a summary of new
paxalisib data presented at the Society for Neuro-Oncology (SNO) Annual Meeting, which is
being held virtually from 19-21 November 2020.
Key Points
• New interim analysis of paxalisib phase II study in glioblastoma (NCT03522298) is
highly consistent with prior data
• Median progression-free survival (PFS) of 8.4 months reported on this analysis
(versus 5.3 months for temozolomide, the existing standard of care)
• Median overall survival (OS) of 17.5 months reported (versus 12.7 months for
temozolomide)
• First substantial presentation of safety data at a 60mg dose shows profile very
similar to prior experience, with the most common toxicities including rash,
stomatitis (mouth ulcers), and hyperglycemia (high blood sugar), consistent with
other PI3K and mTOR inhibitors
• Phase I study in DIPG (NCT03696355) shows paediatric maximum tolerated dose
(MTD) of 27 mg/m2
, with safety profile and pharmacokinetics similar to adult data
Kazia CEO, Dr James Garner, commented, “this is very reassuring data from the glioblastoma
study, confirming our earlier results with the data now much more mature. In studies such
as this, volatility is the enemy of dependability. From the very first efficacy data we reported
from this study, in November 2019, through the ASCO and AACR presentations in June 2020,
to today’s latest analysis, the PFS and OS figures have remained extremely stable as the
study has progressed. This gives us a great deal of confidence that what we are seeing is
representative and reliable.”
He added, “we expect this study to conclude in the first half of calendar 2021, but it has
already provided useful information to guide the development of paxalisib. We have moved
into the operational phase of the GBM AGILE pivotal study, and we expect that study to now
be the primary focus of our work in glioblastoma from this point forward.”