The results were presented by lead investigator
Long-term follow up of the initial 51 patients enrolled in this study that were presented last year at ASH shows there was an incremental improvement in the response rate over time. The ORR increased for this patient subset from 69 percent in 2011 to an ORR of 75 percent in 2012, with the CR increasing from 16 percent to 39 percent over the same period.
"Now with a larger number of patients studied, we see the overall response rate remains durable and the safety profile continues to appear manageable," said Dr. Wang. "In addition, what is particularly encouraging is that with longer follow-up there is an incremental increase in the number of patients who achieve complete response."
Relapsed MCL means the disease has returned after an initial partial or total remission. Refractory MCL refers to cancer that does not respond to current treatment.
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.
"These results are encouraging because they suggest ibrutinib provided a durable response in the treatment of mantle cell lymphoma in this Phase 2 study," said
PCYC-1104-CA is an international, multicenter, open-label, Phase 2, single-agent study that treated 111 relapsed or refractory patients (63 bortezomib-naive and 48 bortezomib-exposed) with oral ibrutinib 560 mg daily for continuous dosing until disease progression. The primary endpoint of the study is ORR. Duration of response and safety evaluation are important secondary endpoints.
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 can spread to other tissues, such as bone marrow and liver. In
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel — regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Data are consistent with a mechanistic model whereby ibrutinib blocks BCR signaling, which drives cells into apoptosis and/or disrupts cell migration and adherence to tumor-protective microenvironments.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. A comprehensive late-stage Phase 2 and 3 program is under way.
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Note: Data in this release correspond to ASH Abstract 904.
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