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On Tuesday, the Leukemia & Lymphoma Society launched the collaborative Phase IIa/IIb Beat AML trial, which will evaluate multiple candidates to treat first-line acute myelogenous leukemia.
The trial will enroll newly diagnosed AML patients aged 60 or older. Patients will be screened using a genomic profiling assay from Foundation Medicine Inc. (NASDAQ:FMI) for hematologic malignancies. Patients will then be assigned to one of four treatment arms based on their genetic profiles.
The treatments in the study are all unapproved agents. They include samalizumab (ALXN6000), an anti-CD200 mAb from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN); BI 836858, an anti-CD33 mAb from Boehringer Ingelheim GmbH (Ingelheim, Germany); entospletinib (GS-9973), an oral spleen tyrosine kinase (SYK) inhibitor from Gilead Sciences Inc. (NASDAQ:GILD); and enasidenib (AG-221), an inhibitor of mutated isocitrate dehydrogenase 2 (IDH2) from Celgene Corp. (NASDAQ:CELG) and Agios Pharmaceuticals Inc. (NASDAQ:AGIO).
The Boehringer and Gilead agents are in Phase II testing for AML, while the Celgene candidate is in a Phase III trial to treat relapsed or refractory AML. The Alexion mAb was previously in clinical trials to treat chronic lymphocytic leukemia (CLL).
LLS said other companies have expressed interest in participating in the trial, which was designed with FDA's input. The patient group expects that Beat AML may eventually include as many as 10 therapies, and will enroll up to 500 patients. Although the trial will not have a control arm, LLS said that data from Beat AML could be used to support FDA approval of the candidates it tests.
LLS, which will hold the IND for Beat AML, said its industry collaborators are also helping to cover some of the trial's costs. Beat AML is expected to start enrolling patients by December.
Original Article: LLS launches collaborative AML trialNEXT ARTICLE