Patients with acute lymphoblastic leukemia (ALL) are initially treated with complex and highly toxic chemotherapy regimens, which may be followed by bone marrow stem cell transplantation for eligible patients. Patients who have a low number of residual tumor cells in their bone marrow after chemotherapy (also known as ‘minimal residual disease’ or MRD) are at a very high risk of early relapse. This Phase II clinical trial recruits patients with MRD and will test whether blinatumomab can eliminate residual tumor cells and prolong the time to relapse.
Blinatumomab is a T cell engaging antibody targeting the CD19 antigen, which is only expressed on B cells. The clinical development program for blinatumomab was expanded to include ALL as an additional indication after data from an ongoing Phase 1 clinical trial showed potent single-agent activity of the BiTE antibody in patients with late-stage non-Hodgkin’s lymphoma.
Carsten Reinhardt, senior vice president and chief medical officer of Micromet, said: “This phase II clinical trial in ALL is an important step to assess activity of blinatumomab in aggressive forms of B cell malignancies and will help to determine the full therapeutic potential of this highly specific and potent BiTE antibody in human B cell cancers.”