About GBM AGILE
GBM AGILE is
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 150 collaborators around the world.
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 allows us to test treatments tailored to patients’ genomic profiles using their individual biological and genomic information. Results are learned as the trial progresses, and this allows 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.
Australians will eventually go through the GBM AGILE system, joining thousands
in the USA, China and Europe, but some important regulatory steps must
still be taken before GBM AGILE opens to patients.
What is Cure Brain Cancer Foundation's role in GBM AGILE?
Cancer Foundation was an early funder and catalyser of GBM AGILE. The
Foundation has been continuously involved in this project from the very
beginning and has been 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 the first couple of months
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 has united to find a solution to one of the most aggressive forms of brain cancer, glioblastoma multiforme, which kills most people within 18 months. Survival rates have remained unacceptably low for 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.
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, 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
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 system, joining thousands in the USA, China and other parts of the world, but a number of important regulatory steps must be taken before GBM AGILE opens to patients and once they have been addressed we will provide a further update in 2017.
After GBM, 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, 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.