April 21, 2014
/PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that data from the Phase III PCYC-1112 (RESONATE
) study of single agent IMBRUVICA
(ibrutinib) vs. ofatumumab, an established therapy in relapsed refractory CLL, as well as data from an Independent Efficacy Evaluation of IMBRUVICA after three years of follow-up, will be presented at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting in
May 30 - June 3
, 2014. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.
"At the interim analysis of the RESONATE Phase III study in January, the data showed that IMBRUVICA improved with statistical significance the overall survival of patients with relapsed or refractory CLL versus ofatumumab, an anti-CD-20 antibody similar to rituximab. IMBRUVICA also provided a significant progression-free survival benefit for these patients," said
John C. Byrd
, M.D., Director, Division of Hematology, The
Ohio State University
Comprehensive Cancer Center – Arthur G. James Cancer Hospital & Richard J. Solove Research Institute and lead investigator on the RESONATE study. "I am excited by the oral, once daily, single agent, 'chemo-free' profile IMBRUVICA offers patients. This class of drugs is transformative to the way we treat patients today. I look forward to providing detailed results of the benefits seen in the IMBRUVICA patients at the ASCO meeting."
"We have two historic oral presentations at this year's ASCO, one showing for the first time a Survival Benefit with IMBRUVICA in a large randomized trial, and the other evaluating the three-year safety and efficacy of IMBRUVICA in relapsed and refractory CLL patients with a median of four prior therapies," said
, CEO and Chairman of Pharmacyclics. "Our team is currently exploring the clinical benefits of IMBRUVICA in 42 clinical trials, of which 10 are large Phase III studies in a broad variety of B-Cell malignancies. With each passing month, I am increasingly pleased with the launch progress we are making, in partnership with our colleagues at Janssen, as we bring IMBRUVICA to market for CLL and MCL patients across
the United States
RESONATE represents the first randomized Phase III study of IMBRUVICA in patients with CLL.