World news – AU – Kazia Therapeutics present paxalisib data confirming previous safety and efficacy results in SNO’s glioblastoma

Phase 2 study of paxalisib is ongoing, with final data expected in the first half of 2021.

Kazia Therapeutics Limited (ASX: KZA) (NASDAQ: KZIA) will present a summary of the new paxalisib data at the Neuro-Oncology Society Annual Meeting, which will take place roughly 19-21 November 2020. .

The new interim analysis to study paxalisib stage 2 in glioblastoma (NCT03522298) is highly consistent with previous data, confirming safety and efficacy results.

“These are very reassuring data from the glioblastoma study, confirming our previous findings with the data now more mature,” said Kasia’s CEO, Dr. James Garner..

“From the first efficacy data we reported from this study, in November 2019, through the presentations of ASCO (American Society for Clinical Oncology) and AACR (American Society for Cancer Research) in June 2020, to the most recent analysis today, the numbers have remained PFS and OS are very stable as the study progresses.

“This gives us a great deal of confidence that what we see is representative and reliable.

“We expect this study to be completed in the first half of the 2021 calendar, but it has already provided useful information to guide the development of paxalisib..

“We have moved to the operational phase of the pivotal study of GBM AGILE, and we expect that this study will now be the main focus of our work on glioblastoma from this point onwards..

Professor Patrick Wynn, first author, added to the poster: “As this study matured, we saw encouraging results that were very stable compared to the successive analyzes, and were fully consistent with previous clinical experience with this drug..

“Paxalisib is now moving to study GBM AGILE in glioblastoma, and we expect this to provide definitive data on the potential use of the drug in this disease and, if successful, provide a basis for regulatory approval”.

“New therapies are still urgently needed in glioblastoma, and paxalisib has proven to be an exciting potential candidate..

The paxalisib phase 2 study is still ongoing, with final data expected in the first half of 2021.

Kazia said the paxalisib arm of the GBM AGILE study has moved into an operational phase and the first patient is expected to arrive in the early first quarter of 2021..

St Jude’s study at DIPG has been ongoing, with final data expected during the first half of 2021.

Median survival (PFS) 8. 4 months were reported in this analysis versus 5. 3 months for temozolomide, the current standard of care.

The first baseline presentation of 60 mg safety data shows a very similar profile to the previous trial, with the most common toxicities including skin rash and stomatitis (mouth ulcers) and hyperglycemia (high blood sugar), consistent with PI3K And other PI3K mTOR inhibitors.

The DIPG Phase 1 Study (NCT03696355) demonstrates the maximum permissible pediatric dose (MTD) of 27 mg / m2, with a safety profile and pharmacokinetics comparable to that of adults.

The SJPI3K study of paxalisib in DIPG and metastatic glioma (NCT03696355), is the first in pediatrics, designed to demonstrate the safety and pharmacokinetics of paxalisib in children, and to explore potential early signs of efficacy in this patient population.

The pharmacokinetics of the drug – the concentration of the drug in plasma over time – was very consistent with the adult experience.

The proportion of patients alive and progress-free at six months (PFS6) was 96%, which compares favorably to the historical control of 58%.

Lead researcher, Dr. Christopher Tinkle said: “We have determined the appropriate dosage for future pediatric work, established an acceptable tolerance profile in children, and demonstrated the kinetic equivalence between intact capsule and open and spray administration, which are critical steps in the development of any new cancer drug. children.

“DIPG is a highly treatment-resistant disease, and no drug has ever shown convincing efficacy as a monotherapy.

“It has always been our opinion that the treatment for this disease will consist of combination therapy, and we have shown that paxalisib is well suited to now be evaluated along with other agents.

“We look forward to discussing follow-up actions that will explore these opportunities and further investigate the potential of paxalisib.

Dr. Garner of Kazia added: “The results provide an excellent basis for further development of paxalisib in DIPG, and we will be excited to discuss the next phase of the work with our partners in the coming months..

The above is posted by Proactive Investors Limited (“the Company”) on its website and is available in accordance with the terms and conditions of use of its website (see T&C).
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James Garner of Kazia Therapeutics Ltd. (ASX: KZA) speaks to Andrew Scott of Proactive shortly after they announced that they have implemented a definitive agreement with the Global Adaptation Research Alliance (GCAR) to begin participating in a pivotal GBM AGILE study in glioblastoma. . The study is scheduled to open. . .

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Kazia Therapeutics, Glioblastoma, NASDAQ: KZIA, ASX: KZA, Glioma