Date: 2011-11-28
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Micromet (USA-Germany)
Product: blinatumomab (MT103)
Action
mechanism: bispecific antibody. 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.
Micromet has received orphan drug designation from the EMA for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the FDA for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
Disease: acute lymphoblastic leukemia
Therapeutic area: Cancer - Oncology
Country: USA, Europe
Trial
details: This single-arm Phase 2 clinical study will enroll approximately 65 adult patients with B-precursor r/r ALL. Patients will receive blinatumomab for up to five treatment cycles. Each cycle will consist of 28 days of treatment followed by two weeks off therapy. The primary endpoint of the study is complete remission (CR) and complete remission with only partial recovery of blood counts (CRh*). Secondary endpoints include duration of CR and CRh* and overall survival. The study will be conducted at leading cancer centers in the U.S. and EU.
Latest
news: * On November 28, 2011, Micromet 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). The Company currently expects to complete enrollment in this trial by year end 2012.
* On October 13, 2011, Micromet has outlined a clinical development plan intended to support U.S. registration of its lead product candidate blinatumomab in patients with B-precursor relapsed/refractory (r/r) acute lymphoblastic leukemia (ALL). The plan incorporates advice received from the FDA within the context of a Type C meeting. Later this quarter, the Company plans to initiate this phase 2 trial.
Micromet also announced it has reviewed with the FDA the preliminary design of a planned randomized, controlled, Phase 3 clinical study intended to evaluate the efficacy and safety of blinatumomab in comparison to chemotherapy in adult patients with r/r B-precursor ALL. Efficacy will be assessed based on blinatumomab's effect on a time dependent endpoint. The study will be conducted at leading cancer centers in the U.S. and in Europe. Data from this trial, if positive, are intended to support full approval of blinatumomab in this patient population.
