Prototype drug shows promise against chronic lymphocytic leukemia
March 28, 2017
The Company recently received clearance from the FDA to conduct a Phase 1/2 clinical study in pediatric and adolescent patients with r/r ALL. This will be an open label two-part study, conducted in collaboration with the Children's Oncology Group and International BFM study group. The first part is designed to determine the appropriate dose and schedule of blinatumomab according to patient age group. Once the recommended dose and schedule is determined, additional patients will be enrolled in the second part of the study to further assess the safety and antitumor activity of blinatumomab. The Company expects to enroll approximately 80 patients at leading investigative sites in the U.S, Canada and EU. Data from this trial will inform the Company's registration strategy in this patient population.
Blinatumomab Clinical Experience in Adult R/R ALL
Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh following treatment with blinatumomab. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.
Source: Micromet, Inc.