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Blinatumomab meets endpoint early in ALL

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The success of Micromet's blinatumomab meeting the primary endpoint in a Phase II study in acute lymphocytic leukemia is being viewed by investors as "striking" results. The study tested the BiTE antibody in 21 patients with minimal residual disease - that is, patients who retain a detectable level of ALL cells in the bone marrow after chemotherapy. Results reported in Berlin at the European Hematology Association June 8 showed that 13 of 16 patients evaluated so far, 81 percent, yielded a response. The study had only to show at least 22 percent response to achieve the primary efficacy endpoint. Patients in all subgroups responded to treatment with blinatumomab. Micromet also is testing the biologic in non-Hodgkin's lymphoma

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