Micromet announced the initiation of a Phase 2 trial of their lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). This single-arm study is intended to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients with B-precursor ALL who are resistant or intolerant to standard chemotherapy. Patients will receive blinatumomab daily for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients will receive starting doses of blinatumomab of 15 micrograms/m2, with dose escalation in subsequent cohorts based on tolerability. The primary endpoint of the study is objective response rate. Secondary endpoints include duration of response and overall survival.
Blinatumomab (MT103) 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.
For more information call (240) 752-1420 or visit www.micromet.com.