Bayer’s Regorafenib is the First Drug to Enter GBM AGILE

The Global Coalition for Adaptive Research (GCAR) and Bayer announced that Bayer’s regorafenib will be the first drug to enter "GBM AGILE" (Glioblastoma Adaptive Global Innovative Learning Environment). GBM AGILE is a revolutionary patient-centered adaptive platform trial that will evaluate multiple therapies for patients with newly diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

"The signals seen with regorafenib in earlier studies warrant further exploration in glioblastoma, a rare cancer where patients are desperately needing new treatment options. We are excited to be the first partner in GBM AGILE, the potentially largest trial ever with an innovative setup that has the possibility to accelerate the evaluation of potentially new effective treatments for patients with glioblastoma, and ultimately could lead to new treatment options for patients," said Dr. Svetlana Kobina, Head of Medical Affairs Oncology at Bayer. "Bayer supports the active clinical research of regorafenib in a range of different tumor types to explore the potential of the compound to help even more patients in need."

GBM treatment options and patient outcomes have remained largely unchanged over several decades and there is no known cure. 95% of patients succumb within five years of diagnosis, with more than half dying within the first 15 months after diagnosis.
GBM AGILE is an international, innovative platform trial designed to more rapidly identify effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial will be conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. Experimental treatments will be added to or dropped from the trial over time. The trial design and infrastructure constitutes a more efficient approach to testing new therapies for GBM, thus bringing new potentially beneficial treatments to patients sooner.

"GBM AGILE is an important step forward for glioblastoma and our patients who desperately need new options. As a more accurate and faster way to evaluate new interventions, we hope to ease the burden of development in glioblastoma and invite more activity in the space," according to Dr. Timothy Cloughesy, the Principal Investigator of GBM AGILE trial, as well as a UCLA professor of clinical neurology.

While GBM AGILE will evaluate multiple investigational drugs over the course of the trial, it will begin with the inclusion of regorafenib in early 2019 led by arm Principal Investigators Dr. Patrick Wen of the Dana Farber Cancer Institute and Harvard Medical School, and Dr. Andrew Lassman of the Department of Neurology and Herbert Irving Comprehensive Cancer Center at Columbia University Irving Medical Center. Regorafenib is an oral multikinase inhibitor that potently blocks multiple protein kinases, including kinases involved in oncogenesis, tumor angiogenesis, and tumor immunity.

"Preclinical rationale and promising results from the phase 2 REGOMA study support the late stage evaluation of regorafenib in patients with glioblastoma. We were encouraged by these results and the purported mechanism of action of regorafenib. These data led to interest in a confirmatory study in recurrent GBM and its evaluation in newly diagnosed patients. The GBM AGILE trial is the perfect solution to achieving these goals simultaneously," said Dr. Patrick Wen. "We look forward to starting the trial early next year."

GBM AGILE was initially conceived in 2015 by over 130 global collaborators - clinicians, researchers, biostatisticians, governments, regulatory agencies, pharmaceutical companies and patient advocacy groups -- under the leadership of Dr. Anna Barker, Co-Director Complex Adaptive Systems, Director, National Biomarker Development Alliance (NBDA) and Professor, Arizona State University; Dr. W.K. Alfred Yung, Professor, Department of Neuro-Oncology, University of Texas MD Anderson Cancer Center; and Dr. Webster Cavenee, Director of Strategic Alliances in Central Nervous System Cancers, Ludwig Institute for Cancer Research and Distinguished Professor, University of California San Diego. Arizona State University (ASU), the ASU Foundation (through the NBDA), the Cure Brain Cancer Foundation, and the National Foundation for Cancer Research provided the leadership and resources needed to plan and design GBM AGILE.

"GBM AGILE is a testament to the many contributors from the international GBM research and advocacy communities who collaboratively ‘crowdsourced’ the knowledge needed to create an adaptive trial that will more efficiently test many therapies, and also serve as a learning system to help oncologists choose the best treatment for every GBM patient. It’s great to see these innovations and the commitments of the GBM AGILE Knowledge Network deployed to support patients," said Dr. Anna Barker.

"The long, difficult and challenging history of developing new drugs for brain cancers underscores the need for a radical transformation in how drugs are brought forward into clinical testing. We now have an alternative solution with GBM AGILE. We are encouraged by the strong commitment of industry to support this important effort, and excited about the involvement of Bayer and the potential of regorafenib to improve patient outcomes," stated Dr. Gary Gordon, Interim Chief Executive Officer of GCAR.

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