National Brain Tumor Society Invests in GBM AGILE, the World’s First Global Adaptive Trial for Glioblastoma Brain Cancer

NBTS provides $750,000 award to the Global Coalition for Adaptive Research to help launch  innovative clinical trial for glioblastoma patients

National Brain Tumor Society (NBTS), the largest nonprofit dedicated to the brain tumor community in the United States, today announced a partnership with the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world’s foremost clinical, translational, and basic science investigators. NBTS has provided GCAR with a $750,000 award to help launch and build patient awareness of the world’s first global “adaptive” clinical trial for brain cancer, GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment).

“The past decade of scientific advances has moved glioblastoma research to a pivotal point which calls for a platform like GBM AGILE to get potentially breakthrough medicines to patients – who can’t afford to wait – faster than standard clinical trial designs,” said David Arons, Chief Executive Officer, National Brain Tumor Society. “GBM AGILE is a ‘game-changer’ for neuro-oncology and is an opportunity for NBTS to collaborate with multiple stakeholders in the brain tumor field to revolutionize the future for patients. This trial also represents the spirit of the NBTS Defeat GBM Research Collaborative program, which was specifically designed to accelerate precision medicine research and take more ‘shots on goal’ by supporting opportunities to find treatments and a cure for the most deadly and aggressive type of brain tumor, glioblastoma.”

GBM AGILE is designed as a learning system to more efficiently and rapidly identify effective therapies for glioblastoma (GBM). GBM AGILE’s innovative model enables multiple drugs (and combinations of drugs) to be screened simultaneously and over time. Drugs that show initial evidence of benefit to patients will seamlessly transition to a confirmatory stage designed to support registration approval. Drugs that are underperforming are dropped. The intent is to lower the cost, time, and number of patients required to evaluate potentially new effective therapies for patients with GBM.

“We are proud to partner with the National Brain Tumor Society, one of the most respected voices in the GBM community,” said Brian Alexander, M.D., M.P.H., Co-founder of GCAR. “As one of the original champions of GBM AGILE, we want to recognize NBTS’s early contributions to the trial design. GCAR is deeply grateful for their confidence, financial support to help launch the trial, and devotion and continued commitment to finding better treatments for this devastating disease.”

“I’m honored to welcome the National Brain Tumor Society as a collaborator and funder to the GBM AGILE platform and am excited in the knowledge that, together, we’re taking a major step toward getting new, more personalized treatments to patients faster,” said Faramarz Yousefzadeh, Chairman of the GCAR Board of Directors, who lost his wife to brain cancer. “I hope many others will follow NBTS’s lead in supporting this important trial so we can conquer brain tumors once and for all.”

In late 2018, GCAR announced a partnership with Bayer Oncology to include the company’s drug regorafenib as the first therapy entering the GBM AGILE platform which will begin in early 2019. Ultimately, the trial will include multiple arms at clinical sites throughout the United States, Canada, and Australia, expanding into Europe and Asia, in the near future.

GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, patient advocates, and leaders from government and industry. NBTS co-sponsored and participated in the early planning meetings, including co-chairing the original GBM Advocates Committee, while the trial was still in its early development stages under the management of the National Biomarker Development Alliance and Dr. Anna Barker of Arizona State University. Many of GCAR and GBM AGILE’s leaders also serve in numerous advisory roles to NBTS, including Dr. Alfred Yung of MD Anderson, who currently is the organization’s Distinguished Research Advisor, and Dr. Webster Cavenee of Ludwig Cancer Research, who serves on the Strategic Scientific Advisory Council for the Defeat GBM Research Collaborative.

Visit http://www.gcaresearch.org/gbm-agile for more about GBM AGILE.

About National Brain Tumor Society

National Brain Tumor Society invests in, mobilizes, and unites the brain tumor community to discover a cure, deliver effective treatments, and advocate for patients and care partners. We are the largest patient advocacy non-profit solely dedicated to the brain tumor community and a leading thought leader in the neuro-oncology field. Headquartered in Newton, Massachusetts, our organization raises funds to invest in accelerating brain tumor treatments, prepare the community to navigate their unique brain tumor experience, and convene stakeholders while changing public policy to improve the lives and survival of brain tumor patients. Visit us at https://braintumor.org.

About Global Coalition for Adaptive Research

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) non-profit charitable organization, comprised of some of the world’s foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases. As its first priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial for patients with glioblastoma (GBM) – the most common and deadliest of malignant primary brain tumors. It is GCAR’s vision is to expand and replicate what is learned using this innovative model for glioblastoma to benefit patients with other rare and deadly diseases. To learn more about GCAR, visit www.gcaresearch.org and follow us at @GCAResearch and www.facebook.com/GCAResearch.