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Pharmacyclics® Announces Updated Results For BTK Inhibitor Ibrutinib (PCI-32765) At American Society Of Hematology (ASH) Annual Meeting

Mantle Cell Lymphoma

At the 2012 ASH Annual Meeting Pharmacyclics and its investigators presented one oral presentation describing the recent clinical trial of ibrutinib in MCL patients. This presentation is available for review on the company's website. The following summarizes the oral presentation showing the recent trial result.

ASH Annual Meeting Oral Presentation Interim Results of an International, Multicenter, Phase 2 Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), in Relapsed or Refractory Mantle Cell Lymphoma (MCL):  Durable Efficacy and Tolerability with Longer Follow-up Michael Wang, M.D., Associate Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center This presentation showed an overall response rate (ORR) in 110 evaluable MCL patients of 68 %, including complete responses (CRs) of 22 % and partial responses (PRs) of 46 % and with a median PFS estimated at 13.9 months. An analysis of the initial 51 patients presented last year at ASH 2011 demonstrated an incremental improvement in the response rate over time. The ORR increased in this subset from 69% as reported at ASH in 2011 to an ORR of 75% as reported at ASH in 2012, with the CR rate increasing from 16% to 39% over the same period. The treatment emergent adverse events were consistent with safety data previously reported for ibrutinib monotherapy.

In addition to this update presented at ASH, Pharmacyclics and its partner Janssen Biotech recently announced the following clinical trials of ibrutinib in relapsed/refractory MCL patients:

Our partner Janssen initiated a single-arm, multi-center Phase II study using ibrutinib as monotherapy in relapsed/refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. The key secondary endpoints include duration of response, progression-free survival rate, and other measures of clinical benefit. This global study is open and Janssen plans to enroll 110 patients worldwide.

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