INC Research, a global phase I to IV CRO, has announced its involvement in The Leukemia & Lymphoma Society’s (LLS) recently-launched precision medicine Master Trial to treat acute myeloid leukemia (AML). The Beat AML Master Trial is breaking ground in a number of areas, including the first time a nonprofit organization is working with multiple biotech and pharma sponsors and other key collaborators to professionally operationalize a study. The trial will provide principal investigators and their patients consolidated access to test novel therapies matched to specific molecular aberrations in AML.
The LLS designed the Beat AML Master Trial as an umbrella trial, which differs from traditional trials in that newly diagnosed AML patients will enter this study based on screening for specific molecular mutations known to be drivers of their disease, and will be matched to a specific targeted therapy for that aberration. The LLS expects the scope of the multi-year trial to include 15 to 20 clinical research sites, up to 10 different treatment arms and 500 patients.
“The Beat AML Master Trial is a significant milestone for LLS, specifically its commitment to helping AML patients, for whom there has not been an advance in standard treatment in more than 40 years,” said Louis J. DeGennaro, Ph.D., LLS president and CEO. “LLS is uniquely able to convene this collaboration, which marks the first time that the organization has functioned as the sponsor of a clinical trial. Working with INC Research will allow us to tap into the Company’s long-established relationships with physicians and medical centers to ensure timely delivery of data, a crucial element of this precision medicine approach.”
INC Research was selected to manage the Beat AML Master Trial based on extensive experience with AML clinical research and the Company’s robust reputation in the field of hematologic malignancies. In the past five years, the company’s Oncology business unit has conducted 40 leukemia studies at more than 1,000 clinical research sites worldwide involving nearly 5,500 patients. INC Research will provide a full range of CRO services for the Master Trial ranging from study startup to project management and clinical operations to biostatistics and medical writing.
“Even though there has been intense clinical trial activity, and research has led to a much deeper understanding of the molecular biology of AML, treatment standards have not been able to advance in the past several years; this remains a disease with poor prognosis,” said Nicholas Kenny, Ph.D., executive vice president and general manager for Oncology at INC Research. “INC’s Oncology team is therefore thrilled to be engaged with LLS in this groundbreaking study. The collaboration LLS has created among biopharma companies, leading AML clinical researchers from the U.S., the FDA and multiple support groups is impressive. We anticipate this will be a landmark trial for AML patients—particularly because it moves multiple targeted therapies into an up-front/newly diagnosed AML setting while concurrently offering physicians and patients a truly targeted approach to the disease.”