CHICAGO, June 4, 2012 /PRNewswire/ -- Pharmacyclics, Inc (Nasdaq: PCYC) announced today updated results from three trials of Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib (PCI-32765), for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
"This meeting at ASCO has been a continued affirmation of the promising activity and clinical benefit of ibrutinib in CLL. It will be exciting to move this toward definitive Phase III study to get this drug approved for CLL patients," said John Byrd, M.D., D. Warren Brown Chair of Leukemia Research and Director, Division of Hematology at Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).
The ibrutinib clinical updates at ASCO released in two oral presentations and a poster discussion session include: 1) safety and efficacy data from the Phase Ib/II CLL/SLL single agent trial in treatment naive patients (PCYC-1102); 2) safety and efficacy data from the Phase Ib/II CLL/SLL combination trial with ofatumumab in relapsed or refractory patients (PCYC-1109); and 3) safety and efficacy data from the Phase Ib/II CLL/SLL combination trial with bendamustine and rituximab in relapsed or refractory patients (PCYC-1108).
Abstract # 6507: The Bruton's tyrosine kinase inhibitor PCI-32765 in treatment-naïve chronic lymphocytic leukemia patients: Interim results of a phase Ib/II study. Dr. John C. Byrd et al., The Ohio State University, Columbus, Ohio.
- Non-hematologic toxicities of ibrutinib single agent remain manageable and tolerable with no new signals; hematologic toxicities were uncommon.
- Overall response rate in the 420 mg cohort is 81% using ibrutinib as a single agent. 12% of patients achieved a complete response with no morphologic evidence of CLL. Progression free survival with a median follow-up of 14.4 months is 96% in the 420 mg cohort.