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Pharmacyclics Announces Data Presentations for Ibrutinib in B-Cell Malignancies
Date:12/10/2013

y Reduces Clonal IgM Paraproteins and Serum Free Light Chains While Increasing Normal IgM, IgA Serum Levels, Suggesting a Nascent Recovery Of Humoral Immunity
Georg Aue, MD, Hematology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD

This study demonstrated ibrutinib's impact on the recovery of humoral immunity equally amongst treatment naive and relapsed refractory CLL patients. Consistent with other reports we see little change in IgG levels in the first 12 months. Importantly, ibrutinib leads to a significant increase in both IgA and IgM serum levels, suggesting a beginning recovery of humoral immunity. The reduction of clonal light chains, a tumor marker, correlates with clinical response. In contrast, the increasing levels of the non-clonal light chain may herald a recovery of the normal B-cell (and possibly plasma cell compartment) raising the possibility that ibrutinib may selectively target CLL cells while allowing the re-growth of normal B-cells.

Poster Abstract #4166: Kinetics Of Chronic Lymphocytic Leukemia Cells In Tissues and Blood During Therapy With The BTK Inhibitor Ibrutinib
Dominik Wodarz, Department of Ecology and Evolutionary Biology, University of California Irvine, Irvine, CA

This two-compartment analysis provides greater insight into ibrutinib's mechanism of action in CLL. During ibrutinib therapy, on average 1.7% (± 1.1%) of the cells die per day in the blood, while in tissue 2.7% (± 0.99%) of the cells die per day. These death rates during treatment are approximately 3-5 times higher than those estimated in previous studies in the absence of treatment. The amount of CLL cells from the tissue that was redistributed into the blood during ibrutinib therapy accounted for an average of 23.3% (± 17%) of the calcula
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SOURCE Pharmacyclics, Inc.
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