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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

SUNNYVALE, Calif., June 16, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today announced the results of two separate Phase 2 studies suggesting that ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, showed efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL). Pharmacyclics sponsored both studies and is jointly developing ibrutinib with Janssen Research & Development, LLC. The data were presented today at the European Hematology Association (EHA) 18th Annual Congress in Stockholm, Sweden.

The findings presented at EHA for patients with MCL or DLBCL expand on the results reported by investigators last year at the American Society of Hematology Congress in December 2012. Ibrutinib was shown to achieve the following key results among patients with relapsed/refractory MCL:

  • An overall response rate (ORR) of 68%, including a complete response (CR) of 21% where all signs of cancer are gone, and a partial response (PR) of 47%.
  • The estimated median duration of response (DOR) in all responding patients was 17.5 months. The median progression-free survival (PFS) was 13.9 months, and the median overall survival (OS) has not yet been reached, but is estimated to be 58% at 18 months.
  • Treatment-emergent adverse events (AEs) reported in greater than 20% of patients included diarrhea (50%), fatigue (41%), nausea (31%), peripheral edema (28%), dyspnea (27%), constipation (25%), upper respiratory tract infection (23%), vomiting (23%) and decreased appetite (21%) and were consistent with previously reported data. Only 8 patients discontinued due to an AE.

Professor Simon Rule,
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SOURCE Pharmacyclics, Inc.
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