The Global Coalition for Adaptive Research (GCAR) announced today that the GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) clinical trial is opening its first clinical site, the Henry Ford Cancer Institute, and will begin enrolling patients this week. GBM AGILE is the world’s first global adaptive clinical trial platform for glioblastoma (GBM), and will ultimately evaluate multiple therapies simultaneously across trial sites on multiple continents for patients with newly diagnosed and recurrent GBM – the deadliest brain cancer.
The FDA has been a strong proponent of modernizing clinical trials with the use of master protocols, including platform trials, to support more efficient and less costly drug development. “Understanding of GBM biology over the past decade has led to few improvements in survival for patients with the disease. One clear barrier to progress is the inefficient clinical trial system for testing and developing new therapies and biomarkers in the clinic,” said Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. “Developing new therapies for patients with GBM will require more engagement from industry and enhanced learning from clinical trials. Platform trials can accelerate the time from discovery in the laboratory to implementation in the clinic. GBM AGILE will raise the bar for all clinical trials.”
GBM AGILE is designed as a learning system to more efficiently and rapidly identify effective therapies for GBM patients. GBM AGILE’s nimble 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 drug approval. Drugs that are underperforming are dropped. The intent is to lower the cost, time, and number of patients required to evaluate potential new, effective therapies for patients with GBM.
By the end of 2019, GBM AGILE will open in over 40 academic medical centers and community-based institutions across the United States, with plans to expand across Europe, China, Canada, and Australia through 2020.
“We seek to improve survival in patients with glioblastoma – of which there is no known prevention or early detection methods, few available treatment options, and no cure,” said Gary Gordon, M.D., Ph.D., President of GCAR. “We are enthusiastic to begin enrollment in GBM AGILE. We believe GBM AGILE’s innovative trial design will ultimately result in better treatments and drive rapid progress in order to make a real difference in patients’ lives.”
While GBM AGILE plans to test multiple drugs from different companies over time, the first drug entering the trial will be Bayer’s drug regorafenib.
“We are excited that the regorafenib arm of the GBM AGILE trial is the first to enroll patients and are looking forward to seeing how regorafenib can potentially help these patients in need of treatment options,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceuticals Division. “Bayer actively supports the clinical research of regorafenib in a range of different tumor types to explore the potential of this drug to help even more patients in need.”
Regorafenib showed preliminary efficacy compared to standard of care in the randomized multi-institutional investigator-sponsored Phase II trial REGOMA, published in The Lancet Oncology in December, 2018.
Henry Ford Cancer Institute, one of Michigan’s largest cancer institutions, is the first clinical site for GBM AGILE. “GBM is an aggressive brain tumor with few effective therapies. We are excited to open GBM AGILE and test new treatment options for our patients, who so desperately need them,” said Tom Mikkelsen, M.D. of the Henry Ford Cancer Institute and medical director of Precision Medicine and Clinical Trials at Henry Ford Health System.
GBM treatment options and patient outcomes have remained largely unchanged over several decades and there is no known cure. Ninety-five percent of patients succumb within five years of diagnosis, while more than half die within the first 15 months after diagnosis.
Driven by the dire need to improve outcomes for patients diagnosed with GBM, GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates.
About Global Coalition for Adaptive Research
The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit 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. Key strategic partners for the GBM AGILE Trial effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research, three nonprofit organizations that are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovating approach to brain tumor treatment development.
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 our website at: www.gcaresearch.org and join us by following us: @GCAResearch and www.facebook.com/GCAResearch.
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