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.
Ridgefield-based Boehringer will provide its investigational anti-CD33 monoclonal antibody, BI 836858, as a treatment for one arm of the trial, which is being touted as the first of its kind. Other pharma participants are Alexion, Celgene, and Gilead Sciences.
The trial will launch initially at 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. LLS anticipates that 500 patients will be treated in the Beat AML Master Trial.
With support and guidance from the U.S. Food and Drug Administration, the trial will use 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 blood cancer mainly affecting people over age 60 and accounts for approximately one third of all adult leukemias in the Western world. 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.