Phase 2 study of blinatumomab (MT103) for the treatment of acute lymphoblastic leukemia (ALL)
Micromet announced updated results from a Phase 2 trial of blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). This multi-center study evaluated the efficacy and safety of blinatumomab in adult patients with B precursor acute lymphoblastic leukemia. Enrolled patients had evidence of leukemic cells in the bone marrow following treatment with front-line chemotherapy, so called minimal residual disease (MRD). The primary endpoint of the study was molecular complete response. Key secondary endpoints included time to hematological relapse, time to molecular relapse and overall incidence and severity of adverse events. Patients received 15mcg/m2 per day of blinatumomab for 28 days followed by 2 weeks off therapy over a 6 week treatment cycle. Patients received up to 7 treatment cycles.
Twenty one patients were treated in the study. Of 20 evaluable patients, 80% (16 out of 20) achieved a complete molecular response, all within the first cycle of treatment. Nine of the patients in the study received an allogeneic stem cell transplant, a toxic procedure that typically carries a high short-term risk of mortality. Notably, all nine transplanted patients were alive 100-days following the transplant.
Blinatumomab (MT103) is a 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.