Independent Data Monitoring Committee Recommends Phase III Study Of IMBRUVICA™ (ibrutinib) Versus Ofatumumab Be Stopped Early Based On Statistically Significant Improvement In Progression Free Survival And Overall Survival
SUNNYVALE, Calif., Jan. 7, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICA TM (ibrutinib) versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival (the primary endpoint of the study, which was evaluated by an independent review committee) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Further, IMBRUVICA showed statistically significant improvement in overall survival (a key secondary endpoint of the trial). The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience. The IDMC recommended that the sponsor provide access to IMBRUVICA for subjects on the ofatumumab arm.
"We are very pleased with the vigilance and professional expertise that our IDMC exercised in monitoring this study. The results seen at the interim analysis of the RESONATE trial are robust and consistent," said Fong Clow, Sc. D, Senior Vice President of Biometrics at Pharmacyclics.
Pharmacyclics has informed the U.S. Food and Drug Administration (FDA) of the recommendations of the IDMC. Similarily, Janssen, the co-developer of IMBRUVICA, has informed the European Medicines Agency (EMA). Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months.
"I am tremendously proud of the accomplishment of the Pharmacyclics team for their effort and execution as well as the collaboration with the clinical sites toward this high quality study. This collaboration resulted in expeditious enrollment, and rapid data collection and analysis. This global study involving 391 patients was conducted at more than 70 clinical sites in 10 countries," said Maria Fardis, PhD, Chief of Oncology Operations and Alliances at Pharmacyclics."We express our appreciation to the patients, the investigators and the entire Pharmacyclics and Janssen teams for overcoming the barriers and challenges associated with this exciting scientific outcome," said Robert Duggan, Chief Executive Officer and Chairman of the Board of Pharmacyclics. The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.
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