What is GBM AGILE?
Glioblastoma Multiforme (also known as GBM) is the deadliest brain cancer and is widely regarded as incurable and universally fatal, killing 95% of patients within five years of diagnosis. NFCR is part of a robust, international coalition working on innovative ways to research the disease: the Global Coalition for Adaptive Research (GCAR).
Led by the best and brightest cancer researchers, GBM AGILE is a revolutionary global collaboration to test and develop new brain cancer treatments. Its personalized approach will allow us to accelerate the discovery of targeted treatments for individual patients.
This global coalition has attracted over 150 participants from more than 40 leading cancer institutions across three continents. It implements a new generation of clinical trials – called “adaptive trials” – which allow patients to be enrolled more quickly, receive treatment(s) based on each patient’s individualized response and does not require years of follow-up to determine whether a new experimental treatment is beneficial. By allowing for multiple new drug combinations and treatments to be used while removing ineffective drugs quickly, this revolutionary approach accelerates research for curing the aggressive form of cancer GBM and will serve as a new clinical research model for combating other cancers as well.
Frequently Asked Questions
Why is GBM AGILE different than other clinical trials?
Efforts to improve patient outcomes is underway by replacing conventional clinical trials with faster, cheaper, more adaptable and more in tune with modern molecular medicine “adaptive trials” like GBM AGILE.
GBM AGILE (Glioblastoma Multiforme Adaptive Global Innovative Learning Environment) is a new generation of adaptive clinical trials that allows patients to be enrolled more quickly, receive treatment(s) based on each patient’s own molecular markers and does not require years of follow-up to determine whether a new experimental treatment is beneficial.
What is the National Foundation for Cancer Research’s role in GBM AGILE?
To take action over one of the world’s deadliest diseases, over 150 researchers from more than 40 leading cancer institutions across four continents have joined forces to find cures for GBM by launching the first-ever global, adaptive clinical trial that will revolutionize how brain cancer treatments are tested and developed.
NFCR is proud to be a strategic partner to GCAR and a founder and major financial supporter of the GBM AGILE initiative, as well as part of the executive steering committee helping to develop and manage the trial protocol.
How do I get on this trial?
GBM AGILE will run trials at multiple locations throughout the world. The protocol is in development, and patient enrollment information will be posted as soon as it becomes available.
Who is eligible to enroll in this trial?
Eligibility criteria is currently being finalized. More details coming soon.
Why is this trial only focused on GBM?
GBM is the most common and the most lethal form of brain cancer in adults. Widely regarded as incurable and universally fatal, GBM kills 95% of patients within five years of diagnosis, with more than half dying within the first 15 months after diagnosis. Although there have been hundreds of standard clinical trials for GBM, there is currently no cure and survival rates for patients with GBM have not improved in any meaningful way in over 30 years. This is unacceptable. Patients with GBM (and their families) desperately need better treatments and better outcomes now.
Will there be AGILE trials for other cancers?
While adaptive trials are not yet commonplace, Congress and the U.S. FDA are focused on accelerating their development to benefit patients. In fact, experts predict that systems like GBM AGILE will eventually become the standard for all cancer clinical trials. For the AGILE team, a potential next phase of AGILE trials would be applying the trial design learned from GBM to cancers such as liver and stomach cancer.
Researchers Working On GBM AGILE
DelMar Pharmaceuticals Receives $500,000 Loan from the National Brain Tumor Society and National Foundation for Cancer Research to Support VAL-083’s Participation in a Pivotal Study for Glioblastoma Sponsored by the Global Coalition for Adaptive Research
SAN DIEGO, June 24, 2020 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies announced today it has received a $500,000 loan from the National Brain Tumor Society (NBTS) and the National Foundation for Cancer Research (NFCR) to support VAL-083’s preparation for participation in the Global Coalition for Adaptive Research’s (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study. On June 4, 2020, the Company announced that VAL-083, its “first-in-class,” small-molecule chemotherapeutic with a novel mechanism of action, was selected by GCAR as the third investigational therapy to participate in GBM AGILE, in which the compounds will be simultaneously evaluated across multiple international trial sites of which 25 are currently activated. DelMar intends to utilize GBM AGILE, which is an adaptive registration clinical trial, to serve as the basis for VAL-083’s new drug application submission and registration. “It means a great deal to all of us involved with VAL-083’s development to receive support from the National Brain Tumor Society and the National Foundation for Cancer Research as these organizations are two of the leading advocacy and funding partners for GBM AGILE,” commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. “This funding is an important milestone as it enables us to accelerate VAL-083’s participation in GBM AGILE, which is expected to reduce VAL-083’s pivotal trial completion and regulatory submission timeline by up to 18 months.” GBM AGILE is an international effort in newly diagnosed and recurrent GBM, utilizing an FDA approved master protocol to evaluate multiple therapies against a common control arm. As an approved registrational study, positive results from the VAL-083 arm of GBM AGILE are expected to be utilized to file for FDA approval. This study employs a cost-efficient, seamless phase 2/3 adaptive trial design with a Stage 1 learning and adapting phase and a Stage 2 expansion and confirmation phase. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR, a 501(c)(3) organization, is the international trial sponsor, and provides financial support for the program infrastructure, as well as trial oversight and management. Comprised of the world’s foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited. “We are supporting the inclusion of VAL-083 in GBM AGILE adaptive clinical trial platform as it is consistent with our mission to support research for, and ultimately enable delivery of, effective treatments to patients with brain tumors. We are particularly pleased to lend our support to VAL-083 given the significant unmet medical need that exists for patients with GBM,” commented David Arons, Chief Executive Officer of the National Brain Tumor Society. Sujuan Ba, President & Chief Executive Officer of the National Foundation for Cancer Research added, “We are dedicated to facilitating the development of therapies for all cancers, and are pleased […]
GBM AGILE – Changing the Way We Fight Brain Cancer
GBM survival rates have not improved in any meaningful way in over 30 years despite desperate efforts. Glioblastoma Multiforme, referred to simply as GBM, is the deadliest type of brain cancer. GBM is widely regarded as incurable and universally fatal, killing 95% of patients within five years of diagnosis. It is a fast-acting cancer that attacks cells meant to support the health of nerve cells within the brain. GBM survival rates have not improved in any meaningful way in over 30 years despite desperate efforts. For years, researchers tried and failed to even come close to finding a potential cure for this disease. Each clinical trial required participation from GBM patients for the better part of a decade. Unfortunately, for a fast-acting and rare disease like GBM, the time required for a successful clinical trial is rarely feasible. Years of hard work and hundreds of millions of dollars were being flushed down the drain, leaving researchers and patients frustrated and seemingly hopeless. Fortunately, the Global Coalition for Adaptive Research (GCAR) took a major leap and decided to challenge the standard clinical trial by introducing GBM AGILE. GCAR is a nonprofit organization comprised of some of the world’s foremost clinical, translational, and basic science investigators, including the National Foundation for Cancer Research. Together, this international group developed GBM Adaptive Global Innovative Learning Environment, or GBM AGILE. GBM AGILE is the world’s first global adaptive clinical trial platform for GBM. It changes the model of traditional clinical trials by evaluating multiple therapies simultaneously, ultimately creating a flexible and adaptable trial approach. This new approach allows researchers to identify drugs that are showing promising results and seamlessly transition to a confirmatory stage designed to support drug approval. Similarly, researchers are able to pinpoint and cull the use of underperforming drugs with minimal time and resources being wasted. Simply put, GBM AGILE is patient-centric and provides a streamlined method for researchers to utilize data connectivity within the trial to answer many questions concurrently. “GBM AGILE allows us to get more researchers involved and allows there to be enough patients enrolled in trials to get statistically significant results,” stated GBM patient Dwayne Osgood. “This sharing of data and information could allow the research to move faster, and ultimately bring lifesaving and life extending treatments to patients faster.” GBM AGILE was the first of its kind, paving the way for further adaptive trials for other cancers. While such trials are not yet commonplace, Congress and the U.S. Food and Drug Administration are focused on accelerating their development to benefit patients. It is anticipated that systems like GBM AGILE will replace the current clinical trial model and become the standard for all cancer trials. While the GBM AGILE team is dedicated to improving outcomes and treatment options for GBM patients, they aim to apply the trial design to other rare and deadly diseases. GBM patients interested in participating in GBM AGILE should explore the current trial sites and contact the research team to learn more. As a founding member of GBM AGILE’s sponsoring body, NFCR has continued to take a leading role in this unprecedented global effort—Dr Sujuan […]