Micromet commences blinatumomab phase 2 trial for r/r B-precursor acute lymphoblastic leukemia

Nov 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.

“In the event that initial data generated from this trial are compelling, we plan to discuss with the FDA potential avenues to accelerate blinatumomab's path to market”

"Relapsed/refractory acute lymphoblastic leukemia is a difficult to treat disease that has seen no meaningful improvement in decades," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and the study's coordinating investigator for Europe. "To date blinatumomab has demonstrated an unprecedented level of efficacy and adequate safety in a patient population with limited therapeutic options."

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.

"In the event that initial data generated from this trial are compelling, we plan to discuss with the FDA potential avenues to accelerate blinatumomab's path to market," said Jan Fagerberg, MD, Ph.D., Micromet's Senior Vice President and Chief Medical Officer.