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Updated Results of Two Phase 2 Ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma
Date:6/16/2013

h the ABC-subtype of DLBCL are difficult to treat, these results are very promising."

About Ibrutinib
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called BTK. BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel — regulation of apoptosis, cell adhesion and cell migration and homing.

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 lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia and multiple myeloma. To date 7 Phase III trials have been initiated with ibrutinib and a total of 30 ongoing trials are currently registered on http://www.clinicaltrials.gov/. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib.

About the MCL Study
111 patients with relapsed/refractory MCL were treated with ibrutinib in this Phase 2 multicenter, open-label, study at 18 sites internationally and had received a median of three prior therapies. Patients were divided into two cohorts based on prior bortezomib exposure – either bortezomib-naive (n=63) or bortezomib-exposed (n=48). Both groups received 560 mg of ibrutinib orally, once a day until disease progression or no longer tolerated by the patient. The primary endpoint of the study was ORR, with secondary endpoints being DOR, PFS, OS and frequency and severity of AEs.

When a disease is described as 'relapsed', it means that it has returned after an initial partial or total remission.[1] 'Refractory' refers to cancer that has become resistant to current treatment.[2]

About the DLBCL Study
The DLBCL study was a Phase 2 multicenter, open-label,
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SOURCE Pharmacyclics, Inc.
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