About GBM AGILE™
GBM AGILE™ will be a revolutionary new way of conducting clinical trials to test potential brain cancer therapies and deliver better treatments faster than traditional clinical trials. It is the biggest global collaboration in the history of brain cancer research, backed by more than 200 collaborators around the world.
Traditionally, pharmaceutical companies test one drug at a time and patients can be on trials for up to two years before they know whether the treatment is working or not. Success or failure is only measured at the end and it can take up to 12 years and more than $1.2 billion to get a new treatment to patients.
GBM AGILE™ is an adaptive clinical trial platform, which tests treatments tailored to patients’ genomic profiles using their individual biological and genomic information. Results will be learned as the trial progresses, and this will allow clinicians to continuously add data and apply those learnings to the next patient who enters the trial.
As well as
testing experimental new therapies, this approach will look at repurposing
treatments for use on brain cancer that are already being tested in other
diseases, saving years of development time.
We are dedicated to bring this trial to Australia for hundreds of patients to access. They will join thousands in the USA, China and Europe, but some important regulatory and financial obstacles steps must still be overcome before GBM AGILE™ opens to patients. It is anticipated the trial will open in the USA in April 2019.
What is Cure Brain Cancer Foundation's role in GBM AGILE™?
Cure Brain Cancer Foundation was an early funder and catalyser of the GBM AGILE™. We are now a strategic partner of the project and have been continuously involved from the very beginning. We remain one of its loudest advocates in the global brain cancer community. The Foundation has also provided counsel and guidance during the development of the complex trial protocol.
How much funding has Cure Brain Cancer Foundation committed to GBM AGILE™?
Cure Brain Cancer Foundation has committed $1.2 million (AUD) to GBM AGILE.
Will Cure Brain Cancer Foundation be committing further funds to GBM AGILE™?
Cancer Foundation has committed a further $1 million to help fund the start-up
costs of the project.
When will the first patients enrol in GBM AGILE™?
It is hoped that the first patients will enrol on GBM AGILE™ in April 2019 in the USA.
Why has patient enrolment for GBM AGILE™ been delayed?
has grown from its origins, welcoming more researchers and scientists to
improve the likelihood of success. The team also engaged in high level
discussions with the Food and Drug Administration in the USA to create a
process that would make it faster for a larger group of patients to access the
promising drugs that are being tested in the trial. This will be done by
allowing a seamless transition from Phase II to Phase III which does not happen
in the current trial format.
a number of important regulatory steps needed to be taken before patients could
be enrolled. All of these factors contributed to the delay in patient
enrolment, but that process will begin very soon.
Where GBM AGILE™ began...
A 150-strong network of the world's brightest minds united to find a solution to the most common and deadly type of brain cancer, glioblastoma , which has an average survival length of 15 months. Survival rates have remained unacceptably low for more than 30 years.
This coalition has created a global, adaptive trial called GBM AGILE™, re-engineering the way clinical trials are conducted to develop more effective treatments faster than ever before. Cure Brain Cancer Foundation and Australian experts are playing a pivotal role in this coalition and Australians will be among the first in the world to benefit.
By speeding up the process, it’s hoped that something will be identified which will more quickly improve survival in brain cancer, which has remained unacceptably low for more than 30 years.
Since GBM AGILE™ will be performed on a global basis, we will finally be able to benefit from the convergence of the basic and clinical research that is driving our progress in neuro-oncology in Australia and across the globe. Moreover, this collaboration will enable recruiting sufficient numbers of patients to learn through the adaptive trial, which therapies do or do not work for GBM.
A/Prof Mustafa Khasraw, GBM AGILE™ Australian Liaison, Medical Oncologist, University of Sydney
See who's involved in the coalition
What makes GBM AGILE™ different
Traditionally, clinical trials are run by biopharmaceutical companies, changing one variable at a time and testing one treatment on many people, irrespective of whether it’s working or not. This takes time, hence it can take up to 12 years to get an experimental drug to market.
The GBM AGILE™ is different because it is an ongoing adaptive trial system. It uses Bayesian statistics and modern imaging at regular intervals to show whether a treatment is working and if it isn’t, the insights gained are used to inform and adapt the treatment tested on the next patient who enters the system.
Hence it is actually a clinical research system rather than a clinical trial, with new patients and treatments entering it and leaving it as insights are gained, in a much faster timeframe.
This is the best opportunity we’ve had to dramatically improve outcomes for people with brain cancer. One of the big problems is that traditional trials leave patients and researchers in the dark for long periods of time about the impact of potential treatments. GBM AGILE™ will change the game completely, with a systematic approach to reveal potential treatments far quicker than has ever been possible.
Michelle Stewart, former CEO, Cure Brain Cancer Foundation
Patients entering the GBM AGILE™ system have their individual tumour’s profile identified using molecular biomarkers so that the right therapy can be tested on the right patients, leading to the development of more effective, personalised medicines.
This new generation of clinical trials will be adaptive based on learning from the patients; global as it is to be performed across the U.S., China, Australia and Europe; and innovative in that it is driven by Bayesian statistics and molecular markers.
Prof Webster Cavenee, GBM AGILE™ Executive Committee & Cure Brain Cancer Foundation Scientific Advisory Committee member
As well as testing experimental new drugs, this approach will look at repurposing treatments already being tested for use in other diseases, saving years of development time and getting new treatments to patients faster.
Uniquely, GBM AGILE™ is also agnostic and will be performed using a “master protocol.” This innovative approach, developed by the U.S. Food and Drug Administration (FDA), will centralize a number of functions for the trial and simplify the efforts needed to add new therapies to the ongoing trial process.
Because of this ‘continuous learning system’ approach, you don’t have to spend time writing new trial protocols or getting ethics approval every time you want to test something new, saving more time.
Australian experts have contributed intellectually to the design of GBM AGILE™ across multiple areas of expertise.
Hundreds of Australians will eventually go through the GBM AGILE™ adaptive research services system, joining thousands in the USA, China and other parts of the world, but anumber of important regulatory steps must be taken before GBM AGILE opens to patients.
If the trial is successful on glioblastoma, the approach can be used by other diseases using similar protocols, so it has the potential to transform clinical research more broadly.
In short, GBM AGILE™ will cut red tape, reduce siloed research and, crucially, share knowledge globally in order to accelerate the development of new treatments to patients.
I don’t think there has ever been a more exciting time to work in brain cancer research. A seismic shift is occurring; this is the moment.
Michelle Stewart, former CEO, Cure Brain Cancer Foundation
There are a lot of new words to get to grips with when announcing a world-first global adaptive trial! Read our GBM AGILE™glossary to see definitions of some of the key terms.