LEXINGTON, Mass.–(BUSINESS WIRE)–#GBMAGILE–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.
For more information about GBM AGILE, please visit GCAResearch.org
and ClinicalTrials.gov
Identifier: NCT03970447.
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.
Contacts
GCAR:
Rachel Rosenstein-Sisson
rrosenstein.sisson@gcaresearch.org