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Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
Date:12/11/2012

edian time to response to treatment with ibrutinib was 1.9 months for first PR (range of 1.4 to 9.1 months) and 5.5 months for first CR (range of 1.7 to 16.4 months).

Safety data were available for 111 patients in the trial. Patients treated with ibrutinib experienced treatment-emergent adverse events (AEs) that were consistent with previously reported data. Treatment-emergent AEs were mainly grade 1 or 2. Treatment-emergent AEs of all grades occurring in 20 percent or more patients were diarrhea, fatigue, nausea, upper respiratory tract infection and dyspnea (shortness of breath). Pneumonia was the only grade 3 or higher treatment-emergent AE occurring in 5 percent or more patients.

"We are encouraged by the rate and durability of response and the tolerability profile suggested in these Phase 2 study follow-up findings, and look forward to enrolling and seeing results from additional Phase 2 and Phase 3 trials," said Peter Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen. "Our collaboration with Pharmacyclics to co-develop ibrutinib in a broad range of B-cell malignancies is part of Janssen's longstanding commitment to apply innovative science to address the most critical unmet needs."

Study Details

PCYC-1104-CA is an international, multicenter, open-label, Phase 2, single-agent study that treated 111 patients (63 bortezomib-naive patients and 48 bortezomib-exposed patients) with relapsed or refractory MCL. Patients were treated with oral ibrutinib 560 mg daily for continuous 28-day cycles until disease progression. The primary endpoint of the study is ORR, and secondary endpoints include duration of response (DOR), PFS, overall survival (OS) and safety/tolerability. The study was conducted by Pharmacyclics.

About Mantle Cell Lymphoma

MCL is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in middle-aged or older adults. The disease typically begins in the lymph nodes but ca
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SOURCE Janssen Research & Development, LLC
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