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."
About Anti-CD33 in Blood Cancers
In leukemia, cancers of the blood and bone marrow, cancerous (malignant) cells multiply in an uncontrolled manner and replace healthy blood cells. On the surface of certain leukemia cells such as acute myeloid leukemia (AML), a protein called CD33 protein is expressed. Using BI 836858, an anti-CD33 monoclonal antibody (mAb) targeting these proteins, is an area of current investigation for the treatment of myeloid malignancies. BI 836858 has been engineered for improved antibody-dependent cell-mediated cytotoxicity (ADCC), a type of immune reaction in which a target cell or microbe is coated with antibodies and killed by certain types of white blood cells. Preclinical studies with the compound have shown promising ADCC against malignant AML cells, warranting further clinical investigation and leading to inclusion in the Beat AML Master Trial.
Other collaborators in the Beat AML Master Trial include Foundation Medicine, a genomics company that will provide comprehensive genetic analyses for enrolled patients; INC Research, a clinical research organization assisting with trial logistics; Protocol First, which will provide a novel web-based digital application to help guide clinicians; and MyClin, providing solutions to facilitate communication between trial sites. Other biopharmaceutical companies involved in the study include Alexion (samalizumab), Celgene (AG-221), and Gilead (entospletinib). Additional treatment arms will be added over time.
About The Leukemia & Lymphoma Society and AML
As the world's largest voluntary health agency dedicated to fighting blood cancer, LLS has been funding AML research since its inception in 1949. Approximately 26 percent of LLS's current research budget is invested in AML research. Beyond the Beat AML Master Trial, LLS has invested nearly $100 million over the past five years alone to better understand and treat this disease. For example, LLS had the vision to make a "down payment" for patients with AML in 2009 by partnering with Celator Pharmaceuticals to advance its drug CPX-351, an innovative formulation of two existing therapies, which recently outperformed standard therapy in a Phase 3 trial. This investment has the potential to become the first new treatment for AML patients in 40 years.
About Boehringer Ingelheim in Oncology
Boehringer Ingelheim's oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for NSCLC that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
For more information please visit http://www.us.boehringer-ingelheim.com/, or follow us on Twitter @BoehringerUS.
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