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Ibrutinib Monotherapy Clinical Trial Data in Patients with Waldenstrom's Macroglobulinemia Presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland
Date:6/20/2013

lished safety profile in other B-cell malignancies. Grade 3 and higher adverse events associated with the treatment of ibrutinib were infrequent with thrombocytopenia and neutropenia seen in 8.6%, and single cases of stomatitis and atrial fibrillation. None of these events led to ibrutinib discontinuation.
  • As of June 3, 2013, 91.4% of patients remain on the study with a minimum of 6 cycles of follow up. The study was extended by an additional 28 patients to further evaluate the safety and efficacy of ibrutinib in WM and a total of 63 patients are now enrolled.
  • "These data suggest that ibrutinib was a highly active and well-tolerated treatment for Waldenstrom's patients in this study, and provide further evidence of the role of BTK in tumor growth," noted Steven Treon, M.D., Ph.D, Director of the Bing Center for Waldenstrom's Research and an attending physician at Dana-Farber Cancer Institute and Brigham and Women's Hospital, in Boston, MA. "Despite the relatively small patient population, there are currently no approved treatments specifically for Waldenstrom's, so the need for novel therapies such as ibrutinib should not be under-estimated."

    About Ibrutinib
    Ibrutinib is an investigational agent designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro environment necessary for survival.

    The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell ly
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    SOURCE Pharmacyclics, Inc.
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