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Kazia Therapeutics interim data from clinical studies reinforces positive efficacy signals

The Cantrixil phase I study is now complete and analysis is underway, with final data expected in the second half of calendar 2020.

The paxalisb phase II study is expected to be completed in 1H CY2021.
The paxalisb phase II study is expected to be completed in 1H CY2021

Kazia Therapeutics Limited (ASX KZA) (NASDAQ: KZIA) has shared poster presentations of interim data from its ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma and from the phase I study of Cantrixil in ovarian cancer.

paxalisib phase II study

Previous paxalisib data presented at ASCO (American Society of Clinical Oncology) was based on Stage 1 (n=9) of the ongoing phase II study in glioblastoma, the most common and aggressive form of primary brain cancer.

This interim analysis at AACR (American Association for Cancer Research) includes all patients in the study (n=30), and therefore provides a more robust and substantial data set (poster link).

The progression-free survival (PFS) for paxalisib is now 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 phase I study

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).

Poster link.

Increasing confidence in clinical programs

Kazia CEO Dr James Garner said: “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.”

Next steps

The paxalisb phase II study remains ongoing with a number of patients in follow-up and about half of the total enrolled patient population still receiving the 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.

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