Company News: Micromet Initiates Global Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia


Monday, November 28, 2011

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Company News: Micromet Presents Updated Results From Phase 1 and Phase 2 Study of Blinatumomab


Monday, June 14, 2010

- Update Presented at the 15th Annual Congress of the European Hematology Association (EHA) -

Micromet, Inc. (NASDAQ: MITI) today announced updated clinical data from a Phase 1 and a Phase 2 trial, respectively, of its lead product blinatumomab (MT103). The data were presented at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

Results of the analysis from a Phase 2 trial in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL) demonstrate that a prolonged hematologic relapse-free survival was observed in patients treated with blinatumomab. A pivotal trial in adult MRD-positive ALL patients is scheduled to begin in Q3, 2010.