Micromet begins blinatumomab Phase 2 trial

Blinatumomab is a next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin’s lymphomas.

The single-arm study is designed to assess safety and efficacy of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL.

The primary endpoint of the study is CR/CRh.

Secondary endpoints include duration of response and overall survival.

Study coordinating investigator and University of Wuerzburg Department of Internal Medicine II, professor Max Topp said to date blinatumomab has demonstrated an unprecedented level of efficacy and adequate safety in a patient population with limited therapeutic options.

Micromet senior vice president and chief medical officer Jan Fagerberg said they plan to discuss with the US Food and Drug Administration (FDA) potential avenues to accelerate blinatumomab’s path to market.