RARITAN, NJ, May 31, 2014 – Data from the international, multicenter Phase 3 PCYC-1112 (RESONATE™) trial in 391 patients suggest single-agent ibrutinib (IMBRUVICA®) administered once-daily significantly lengthened progression-free survival (PFS) (median not reached vs. 8.1 months; HR 0.215, 95% CI, 0.146 to 0.317; P<0.0001) and overall survival (OS) (HR 0.434; 95 CI, 0.238 to 0.789; P=0.0049) versus ofatumumab administered intravenously in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Janssen Research & Development, LLC, announced today the data will be included in a presentation today during the official press program at the American Society of Clinical Oncology (ASCO) meeting in Chicago, IL and simultaneously published in a special edition of The New England Journal of Medicine.
PFS is the primary endpoint of the RESONATE study, with OS, overall response rate (ORR) and safety as key secondary endpoints. These data will be presented in full by Dr. John Byrd during the oral abstract session on Tuesday, June 3 during the Leukemia, Myelodysplasia, and Transplantation track at 11:57 a.m. CDT.
Ibrutinib (IMBRUVICA®) RESONATE™ Data Show Significant Improvements in Progression-Free Survival and Overall Survival in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Johnson & Johnson
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