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Pharmacyclics Reports Third Quarter 2013 Results
Date:11/7/2013

ients with R/R follicular lymphoma (FL) started in the second quarter of 2013. This is a multi-center, global trial of ibrutinib in patients with chemoimmunotherapy-resistant FL, whose disease has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen. The primary endpoint of this study is overall response rate. The enrollment target of this global study is 110 patients.
  • FLR3001: Phase III study of ibrutinib in patients with R/R indolent Non-Hodgkin's Lymphoma (iNHL) was initiated in the third quarter of 2013. This is a multi-center, global trial of ibrutinib in patients with chemoimmunotherapy-experienced FL and marginal zone lymphoma (MZL), whose disease has relapsed from at least 1 prior therapy. The primary endpoint of this study is progression free survival. The enrollment target of this global study is 400 patients.
  • WM

  • Phase II study of ibrutinib in patients with R/R Waldenstrom's Macroglobulinemia (WM) was started in the second quarter of 2012. This is a multicenter, open label study with a primary endpoint of ORR and is currently exploring ibrutinib administration at 420 mg in patients with WM who have failed at least 1 prior therapy. The study will also assess the safety and tolerability of ibrutinib as well as progression-free survival. This study is sponsored by the Dana-Farber Cancer Institute and completed enrollment of 63 patients.
  • MM

  • PCYC-1111: Phase II study of ibrutinib in patients with R/R multiple myeloma (MM) started in the first quarter of 2012. This is a Phase II, multi-center, open-label trial designed to assess the safety and efficacy of ibrutinib single agent and in combination with dexamethasone in patients with R/R MM. This study is conducted by Pharmacyclics and is currently exploring ibrutinib administration at 560 mg in combination with dexamethasone and 840 mg in combination with dexamethasone and 840 mg as a single
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  • SOURCE Pharmacyclics, Inc.
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