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New Treatment Arms Opening for Patients in NBTS-Funded GBM AGILE Clinical Trial

Yesterday, it was announced that the GBM AGILE adaptive clinical trial platform is opening two new treatment arms, with one evaluating Kintara Therapeutics’s chemotherapy, VAL-083, and Kazia Therapeutics’s targeted therapy, paxalisib. 

“NBTS has long supported GBM AGILE as a scientifically cutting-edge and more patient-friendly way to develop and evaluate emerging new treatments for patients,” says David Arons, chief executive officer, National Brain Tumor Society. “As a patient advocacy partner to the GBM AGILE program, we’re truly encouraged to see the trial expand toward realizing its potential as a dynamic system to support drug development for glioblastoma. Today’s exciting news means more opportunities for glioblastoma patients to access promising therapies in development and offers the hope of new treatment approvals for a patient population that currently lacks adequate options to fight this devastating disease. With the urgency of now, GBM AGILE is exactly the kind of innovation we need in brain tumor clinical research to change the unacceptable status quo facing patients and their families with glioblastoma.”

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is what’s known as an “adaptive clinical trial platform.” Adaptive platform trials offer a unique system for the discovery and testing of various experimental drugs and create a more efficient and cost-effective mechanism for accelerating treatments to patients. The “platform,” or “master protocol,” aspect of the trial allows for testing of more than one investigational drug, and GBM AGILE will simultaneously evaluate multiple therapies for newly diagnosed and recurrent GBM patients and identify effective new treatments for subtypes of this tumor based on patients’ biological characteristics in a rapid manner.

GBM AGILE opened for patient enrollment in 2019 with its first arm studying the drug regorafenib (developed by Bayer Oncology). The addition of paxalisib and VAL-083 arms will provide the GBM AGILE platform with two new, promising therapies, both of which have shown encouraging results from early-phase clinical trials.

According to yesterday’s release, both new arms will enroll newly diagnosed and recurrent GBM patients. Henry Ford Cancer Institute in Detroit will be the first trial site to enroll patients on these arms, which will subsequently open at over 30 trial sites across the United States with additional global sites in Canada, Europe, and China to follow. 

GBM AGILE 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. As an adaptive study, the number of patients recruited for GBM AGILE arms, and their allocation within the study, will be continuously adjusted in the light of emerging results. This is considered a more efficient approach to drug development, and one that has received significant interest and support from clinicians, industry, and regulatory agencies. NBTS believes this design will allow new potential treatments being tested to move the trial process much faster and require significantly fewer patients, especially for the control arm. We also believe these benefits will be attractive to the companies that make drugs, encouraging even more of them to take shots at developing drugs for brain tumors, creating a multiplying effect. 

NBTS was there when the concept for this type of adaptive trial was first born in a meeting with leaders from across the neuro-oncology field, when the trial was announced with fanfare (including a cameo from then Vice President, and now, President-elect Joe Biden) in Washington, D.C., and made two substantial investments in the trial’s operations in 2019, totaling more than $1.25 million. We continue to support GBM AGILE as a major, revolutionary approach to clinical trials for brain tumor patients. We will keep the community updated when we learn important news about the trial. To learn more visit: https://braintumor.org/our-research/gbmagile/

“NBTS thanks the Global Coalition for Adaptive Research, who are sponsoring GBM AGILE; the trial’s investigators; the biopharmaceutical companies involved; and other platform partners, including NFCR and StacheStrong, together with support from the Uncle Kory Foundation, for their collaborative work to get to this important milestone,” Mr. Arons added. “We also offer our deepest appreciation and support for the patients and families who are or will be participating in this pivotal trial.” 

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