Pharmacyclics, Inc. (PCYC) recently announced the completion of enrollment in its phase III study RESONATE, which is being conducted to evaluate ibrutinib versus Arzerra (ofatumumab) in patients with relapsed or refractory chronic lymphocytic leukemia (:CLL)/small lymphocyctic lymphoma (:SLL).
On Apr 3, 2013, Pharmacyclics completed the enrollment target of 350 patients into this study. An additional 41 patients were screened and allowed to participate in the study.
Progression-free survival (PFS) is the primary endpoint of this study. Pharmacyclics is likely to present data from an interim analysis during the first quarter of 2014. If the interim analysis shows that ibrutinib’s treatment effect is statistically more significant than that of Arzerra, then the company may pursue discussions with the FDA and other regulatory authorities for an early filing of the candidate.
On Aug 1, 2012, Pharmacyclics had announced the enrollment of the fifth patient in this study which triggered a $50 million milestone payment from Janssen Biotech, Inc., a Johnson & Johnson (JNJ) company.
Pharmacyclics and Janssen’s agreement dates back to Dec 2011. The companies are collaborating for the global development and commercialization of ibrutinib. In addition to receiving a $150 million upfront payment from Janssen, Pharmacyclics is entitled to receive up to $825 million (of which $200 million has been earned) on the achievement of development and regulatory milestones.
Pharmacyclics also finished enrolling 110 patients in a phase II study, SPARK, which is being conducted to evaluate ibrutinib in mantle cell lymphoma (:MCL) patients whose disease has progressed even after having received Velcade (bortezomib) therapy and at least one prior Rituxan (rituximab)-containing chemotherapy regimen.
Pharmacyclics expects to file a New Drug Application (:NDA) with the US Food and Drug Administration (:FDA) for the use of ibrutinib in patients with relapsed or refractory MCL before the end of 2013.
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