SYDNEY, June 22, 2020
/PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ:
KZIA), an Australian oncology-focused biotechnology company, is
pleased to share poster presentations of interim data from the
ongoing phase II study of paxalisib (formerly GDC-0084) in
glioblastoma, the most common and most aggressive form of primary
brain cancer, and from the phase I study of Cantrixil in ovarian
cancer.
Key Points
- Previous paxalisib data presented at ASCO was based on Stage 1
(n=9) of the ongoing phase II study in glioblastoma. This interim
analysis at AACR includes all patients in the study (n=30), and
therefore provides a more robust and substantial data set
- Progression-free survival (PFS) for paxalisib is 8.5 months,
versus 8.4 months in the previous analysis
- Paxalisib overall survival (OS) remains at 17.7 months, in line
with ASCO data
- A separate poster on the investigator-initiated study of
paxalisib in combination with radiotherapy is presented by
clinicians at Memorial Sloan Kettering Cancer Center in
New York. It noted a 'robust
response' in the first treated patient
- Cantrixil data shows one complete response (CR) to treatment,
meaning no measurable disease, and two partial responses (PR), for
an overall response rate of 19% (3 / 16 evaluable patients)
Summary of Paxalisib Data in Comparison to Temozolomide
(existing standard of care)
|
Temozolomide[1]
(FDA-approved treatment)
|
Paxalisib
(interim phase II
data)
|
Progression-Free
Survival (PFS)
|
5.3 months
|
8.5 months
|
Overall Survival
(OS)
|
12.7
months
|
17.7
months
|
Kazia CEO, Dr James Garner,
commented, "The data summarized in these posters help to strengthen
our confidence in both our clinical programs. As paxalisib moves
towards commencement of the GBM AGILE pivotal study in the second
half of calendar 2020, these findings will be used to support
set-up activities. In the meantime, the fact that the PFS has
remained robust as the analysis is extended out to the full data
set gives us a great deal of additional confidence in the efficacy
signal it provides. For Cantrixil, the emergence of one complete
responder (CR) to treatment is very positive, and these new results
will help us to explore partnering opportunities over the second
half of the year."
AACR Annual Meeting
The American Association of Cancer Research (AACR) Annual
Meeting is one of the leading global academic conferences for
oncology research. It is typically attended by more than 20,000
clinicians, researchers, industry executives, and investors,
representing over 140 countries. The conference is being conducted
through a virtual format this year and has been broken into two
sections. AACR Virtual Meeting I took place 27-28 April 2020, and AACR Virtual Meeting II is
being held 22-24 June 2020.
The paxalisib poster is found under number CT205 (NCT03522298),
and the Cantrixil poster under CT166 (NCT02903771). Registration to
the virtual meeting is free and interested parties may register via
the AACR website. The posters can be viewed on our website:
https://kza.irmau.com/irm/PDF/42fa1764-4329-42d8-9fbc-c9e2433b3ecc/PaxalisibposterpresentedatAACRvirtualmeeting
https://kza.irmau.com/irm/PDF/e55c6c96-c2c8-4aa1-ad7f-369d771857ca/CantrixilposterpresentedatAACRvirtualmeeting
Initial Data from Memorial Sloan-Kettering Study of Paxalisib
with Radiotherapy
Dr Jonathan Yang and team at
Memorial Sloan Kettering Cancer Center in New York, NY, also presented a poster (number
CT252) on their ongoing phase I study of paxalisib in combination
with radiotherapy (NCT04192981). The poster principally reported
the design of their study, but also noted a 'robust response' in
the first patient treated. Further data is expected as the study
progresses
Next Steps
The paxalisb phase II study remains ongoing with a number of
patients in follow-up and approximately half of the total enrolled
patient population still receiving drug at the time of analysis.
Kazia expects to complete the study in 1H CY2021.
Set-up work is well underway for paxalisib's planned entry into
the GBM AGILE pivotal study, and it is expected that the first
patient will be enrolled in the second half of calendar 2020.
The Cantrixil phase I study is now complete and analysis is
underway, with final data expected in the second half of calendar
2020.
[1] ME Hegi, A-C Desirens, T Gorlia,
et al. N Engl J Med (2005); 352:997-1003
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SOURCE Kazia Therapeutics Ltd