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Pharmacyclics Reports Second Quarter 2013 Results
Date:7/31/2013

I study of ibrutinib in combination with bendamustine and rituximab in patients with R/R CLL/SLL. This trial is a randomized, multi-center, double-blinded, placebo-controlled trial of ibrutinib in combination with bendamustine and rituximab versus placebo in combination with bendamustine and rituximab in R/R CLL/SLL patients who received at least one line of prior systemic therapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in PFS when compared to bendamustine and rituximab. This global study, conducted by Janssen, is recruiting and Janssen plans to enroll 580 patients worldwide.
  • NCI STUDY: Phase III study of ibrutinib alone compared to ibrutinib in combination with rituximab or compared to rituximab in combination with bendamustine in treatment naive older CLL patients. This trial is a randomized trial of ibrutinib in treating patients 65 years or older with previously untreated CLL and is being initiated by the National Cancer Institute (NCI). The primary endpoint of the study is PFS. This study is not yet recruiting and the NCI plans to enroll 523 patients.
  • MCL

  • SPARK (MCL2001): Phase II study of ibrutinib in patients with R/R MCL who progressed after bortezomib therapy. This is a single-arm, multi-center trial of ibrutinib as a monotherapy in R/R 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 ORR, which is scheduled to be evaluated 6 months from the completion of enrollment. This global study, conducted by Janssen, has completed enrollment of the planned 110 patients in April 2013.
  • RAY (MCL3001): Phase III study of ibrutinib versus temsirolimus in R/R MCL patients. This trial is a randomized, multi-center, open-label trial of ibrutinib as a monotherapy versus temsirolimus in R/R MCL patients who received at least one prior rituximab-containing chemotherapy regi
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  • SOURCE Pharmacyclics, Inc.
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