Boehringer Ingelheim announced that it will join The Leukemia & Lymphoma Society (LLS) in a groundbreaking, first-of-its-kind collaborative trial program to advance treatments for patients with acute myeloid leukemia (AML). The Beat AML Master Trial will evaluate investigational medicines from several biopharmaceutical companies and will enroll newly-diagnosed patients who will be assigned to a treatment arm based on genomic analysis. Boehringer Ingelheim will provide its investigational anti-CD33 monoclonal antibody, BI 836858, as a treatment for one arm of the trial.
"Beat AML demonstrates The Leukemia & Lymphoma Society's ability to convene medical and research communities, including biopharmaceutical companies like Boehringer Ingelheim, to think and act boldly in the quest for new and better treatments for blood cancer patients," said Louis J. DeGennaro, Ph.D., LLS President and CEO. "Our aim is to accelerate the rate at which precisely targeted breakthrough therapies reach patients who urgently need them."
With support and guidance from the U.S. Food and Drug Administration, the LLS' ambitious Beat AML Master Trial seeks to change the paradigm for how this deadly cancer is treated, using an innovative precision medicine protocol. The trial will employ the latest genomic technology to find and match specific AML mutations, in newly-diagnosed patients over the age of 60, with an investigational drug or drugs best suited to attack the specific genetic mutations which are found within the cancer.
AML is an aggressive and devastating blood cancer mainly affecting people over age 60. It is one of the most common types of acute leukemia in adults, accounting for approximately one third of all adult leukemias in the Western world and with one of the lowest survival rates of all leukemias. Responsible for more than 10,000 deaths annually in the U.S., it is the most lethal of the blood cancers, which together are the third leading cause of cancer deaths in the U.S.
The trial will launch initially at five leading cancer centers: The Ohio State University, Memorial-Sloan Kettering Cancer Center, Oregon Health and Science University, Dana-Farber Cancer Institute and Massachusetts General. The first patients are expected to be enrolled by December 2016, and six additional clinical sites are prepared to begin enrolling patients in April 2017, with the goal of eventually expanding to between 15 and 20 sites, with up to 10 treatment arms. LLS anticipates that 500 patients will be treated in the Beat AML Master Trial.
"This is a unique opportunity to put the interests of a particularly underserved patient population front and center by bringing multiple biopharmaceutical companies with investigational medicines targeting AML together," said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim. "Boehringer Ingelheim is proud to join other leading experts and medical centers to take part in this pioneering initiative."