Oncology-focused biotechnology company Kazia Therapeutics Limited (ASX: KZA) has executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to commence Kazia’s participation in the GBM AGILE pivotal study in glioblastoma.
CEO, Dr James Garner, said the study will open a new arm with Kazia’s investigational new drug, paxalisib and will now move into an operational phase with recruitment of patients to the paxalisib arm expected to begin in Q1 CY2021.
Key Points
- GBM AGILE (NCT03970447) is intended to serve as the pivotal study for registration of paxalisib in key markets
- Kazia will pay an initial fee of US$5 million to GCAR, with further milestone payments payable throughout the course of the study
- The duration of paxalisib’s enrollment period in GBM AGILE is expected to total approximately 30 – 36 months, plus follow-up, but will depend on emerging study data, recruitment rates, and other variables
We have spent the last nine months or so working closely with the GCAR team to plan paxalisib’s entry into GBM AGILE, and we are very gratified to now be moving into the operational phase of the study,” Dr Garner said.
“GBM AGILE is truly a ground-breaking clinical trial, driven by some of the world’s leading experts in the field, and we are proud to be a part of it. We expect GBM AGILE to provide definitive clinical evidence for the approval of paxalisib by regulatory agencies in key markets.
“This is a faster, more cost effective, and higher quality study than any company of our size could mount independently, and we are confident that it will provide the best possible opportunity for paxalisib to demonstrate its potential in this very challenging disease.”
Dr Meredith Buxton, Chief Executive Officer at GCAR, said the mission is to help drive the development of new therapies for glioblastoma, by creating an efficient model for testing and confirming new potentially beneficial treatments for patients with GBM.
“We look forward to continuing to work closely with the Kazia team to bring paxalisib into the study and support its evaluation,” Dr Buxton added.
GBM AGILE is an adaptive study, so the number of patients recruited, and their allocation within the study, will be continuously adjusted in the light of emerging results. It is expected that between 50 and 200 patients will receive paxalisib, depending on the safety and efficacy of the drug.
The data from these patients will be compared against data from an estimated several hundred patients in a shared control arm, allowing for considerable operational efficiency.
The paxalisib arm of GBM AGILE will recruit newly diagnosed patients with unmethylated MGMT promotor status, which is the same population that has been investigated in Kazia’s ongoing phase II study. In addition, GBM AGILE will recruit recurrent patients to the paxalisib arm. The drug may ultimately be considered efficacious in either or both of these patient groups, and Kazia will frame any future application for regulatory approval on the basis of this data.
