Ibrutinib: Phase II data

Data from 35 evaluable patients with relapsed or refractory Waldenstrom's macroglobulinemia in an open-label, U.S. Phase II trial showed that once-daily oral ibrutinib led to an ORR of 83%, including a very good partial response rate of 11.4%, a partial response rate of 54% and a minor response rate of 17.1%. Additionally, six 4-week cycles of ibrutinib significantly reduced bone marrow disease burden to 40% from 70% at baseline (p=0.0004) and significantly reduced levels of IgM to 1,232 mg/dL from 3,190 mg/dL at baseline (p<0.001). Grade 3 and higher adverse events included thrombocytopenia and neutropenia, with single cases of stomatitis and atrial fibrillation (AF) also reported. The trial, which was sponsored by the Dana-Farber Cancer Institute, has enrolled 63 patients. Data were presented at the Malignant Lymphoma meeting in Lugano. ...