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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

SUNNYVALE, Calif., June 20, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today announced results of a study evaluating ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor in patients with Waldenstrom's Macroglobulinemia (WM). Pharmacyclics is jointly developing ibrutinib with Janssen Research & Development, LLC. The data were presented today at the International Conference on Malignant Lymphoma (ICML), taking place in Lugano, Switzerland.

A Phase II study examining the efficacy and tolerability of ibrutinib in patients with relapsed/refractory WM was led by Dr. Steven Treon at the Bing Center for Waldenstrom's Research in Boston, MA. In WM the malignant B-cells produce large amounts of a normal antibody called immunoglobulin M (IgM). Antibodies such as IgM help the body to fight infection; however, in WM excess IgM causes the blood to thicken and causes many of the symptoms of the disease.[1],[2]

Thirty five relapsed/refractory WM patients who received a median of 2 prior therapies were evaluated. Key findings presented at ICML include:

  • The best overall response rate was 83% (11.4% very good partial response; 54.3% partial response; 17.1% minor response)
  • After six treatment cycles (a cycle = 4 weeks of treatment) bone marrow disease burden decreased from 70% down to 40% (p=0.0004)
  • Levels of IgM reduced from 3,190 mg/dL at baseline to 1,232 mg/dL (6 cycles best response; p=5.1x10-9)
  • Red blood cell production improved with levels of hematocrit increasing from 30.8% to 39.7% (6 cycles best response; p=1.1x10-11)
  • The safety profile observed in patients with WM was similar to the estab
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SOURCE Pharmacyclics, Inc.
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3. Updated Results of Two Phase 2 Ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma
4. Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
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9. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
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