Blinatumomab: Phase II data

Data from 36 evaluable adults with B-precursor ALL who relapsed following standard front-line chemotherapy or allogeneic stem cell transplant in a single-arm, dose-ranging, international Phase II trial showed that 26 (72%) patients achieved a CR or CR with partial recovery of blood counts following treatment with once-daily 5-30 µg/m 2 blinatumomab. Additionally, 34 patients achieved a molecular response, defined as no evidence of leukemic cells in the blood or bone marrow. At a median follow-up of 10.7 months, median survival was 9 months and median duration of response in the 26 responders was 8.9 months. No treatment-related deaths or serious adverse events were reported. The most common grade 1/2 adverse events were pyrexia, headache, tremor and fatigue. Reversible CNS events led to treatment interruptions in 6 patients, with 2 discontinuations. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...