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Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

ther information about this program can be found on www.clinicaltrials.gov.
  • Phase III study of ibrutinib versus ofatumumab in patients with R/R CLL/SLL, RESONATE™. This trial is a randomized, multi-center, open-label Phase III trial of ibrutinib as a monotherapy. The target enrollment of 350 patients was achieved on April 3, 2013 and the study was closed for further enrollment on April 18, 2013 with an additional 41 patients enrolled at that time. The primary endpoint of this study is to demonstrate a clinically significant improvement in progression-free survival when compared to ofatumumab. A pre-defined number of progression events will trigger an interim analysis. A read out from the interim analysis is expected during Q1 of 2014. If the treatment effect of ibrutinib in comparison to ofatumumab is deemed statistically favorable by an independent review committee, a discussion with the FDA and other health authorities for a potential early filing may take place.
  • Phase III study of ibrutinib versus chlorambucil in frontline newly diagnosed elderly CLL/SLL patients, RESONATE™-2.  This trial is a randomized, multicenter, open-label study of ibrutinib as a monotherapy versus chlorambucil in patients 65 years or older with treatment naïve CLL/SLL. The study design was granted a Special Protocol Assessment (SPA), designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival when compared to chlorambucil. This global study enrolled its first patient at the end of Q1 of 2013. Pharmacyclics plans to enroll 272 patients worldwide and anticipates enrollment for this study to be completed by the end of Q3 of 2014.
  • Phase III study of ibrutinib in combination with bendamustine and rituximab in patients with R/R CLL/SLL, HELIOS (CLL3001). This trial is a randomized, multi-center, double blinded, placebo controlled trial of ibrutinib in com
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  • SOURCE Pharmacyclics, Inc.
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