Trials of BiTEs for the treatment of acute leukemias

Ralf Bargou, MD, from Würzburg University Hospital, Würzburg, Germany, introduces trials of bispecific T-cell engagers (BiTEs) for the treatment of acute leukemias at the International Symposium on Acute Leukemias (ISAL) 2017 in Munich, Germany. He describes clinical breakthroughs in the use of the BiTE antibody blinatumomab in patients with B-cell malignancies, as well as new clinical data on blinatumomab in acute lymphoblastic leukemia (ALL). Prof. Bargou speaks about the first Phase I clinical trial with blinatumomab, which was performed in non-Hodgkin lymphoma and showed a surprisingly high response rate in relapsed and refractory patients (NCT00274742). Based on these results, a Phase II trial was carried out in ALL in the minimal residual disease (MRD) setting, which had a molecular response rate of 80% (NCT00560794). The confirmatory Phase II BLAST trial (NCT01207388) subsequently showed favorable relapse and overall survival (OS) data in these patients. Prof. Bargou also highlights several key Phase II trials of blinatumomab in relapsed and refractory patients with advanced hematological malignancies, which demonstrated that patients in the relapse setting also benefit from BiTE treatment with blinatumomab, as well as recent data confirming these findings in a prospective Phase III trial (NCT02013167). Finally, he outlines the mechanism of action of BiTE antibodies such as blinatumomab, which engage T-cells in an MHC-independent manner, which works well in B-cell malignancies and has also been demonstrated by the chimeric antigen receptor (CAR) T-cell receptor approach using the same antigen, namely CD19.

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