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

el, multi-center trial using ibrutinib as a monotherapy in patients who have deletion 17p and who did not respond to or relapsed after at least one prior treatment (a high unmet need population) started in the first quarter of 2013. The primary endpoint of the study is overall response rate (ORR). This global study completed its enrollment of 145 patients more than two quarters ahead of schedule.
  • RESONATE™-2 (PCYC-1115): Phase III study of ibrutinib versus chlorambucil in frontline newly diagnosed elderly CLL/SLL patients started in the first quarter of 2013. This is a randomized, multicenter, open-label trial of ibrutinib as a monotherapy versus chlorambucil in patients 65 years or older with treatment naïve CLL/SLL. The study design was agreed upon with the FDA under a Special Protocol Assessment (SPA). The study is designed to demonstrate superiority of ibrutinib with the primary endpoint of PFS when compared to chlorambucil. Pharmacyclics plans to enroll 272 patients worldwide and enrollment is now targeted to be completed by the second quarter of 2014, one quarter earlier than previously announced.
  • HELIOS (CLL3001): Phase III study of ibrutinib in combination with bendamustine and rituximab in patients with R/R CLL/SLL started enrolling patients in the third quarter of 2012. This 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. The enrollment target of this global study is 580 patients.
  • MCL

  • SPARK (MCL2001): Phase II study of ibrutinib in patients with R/R MCL who progressed after bortezomib therapy started in the third quarter of 2012. This is a
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  • SOURCE Pharmacyclics, Inc.
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