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Ibrutinib Phase 2 Study Results in Patients with Mantle Cell Lymphoma Published in The New England Journal of Medicine
Date:6/19/2013

are gone. The estimated median response duration was 17.5 months. The median progression free survival was 13.9 months and while the median overall survival for this study has not yet been reached it is estimated to be 58 percent at 18 months. The overall response to ibrutinib was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognosis, bulky disease, gender or age. In an initial subset of patients enrolled in the study who have the longest follow up (n=51), the response to ibrutinib increased with longer duration of treatment, with the complete response rate increasing from 16 percent at a median follow-up of 3.7 months to 37 percent at a median follow-up of 18.2 months.

The majority of adverse events (AEs) were Grade 1 or 2 in severity, with the most common AEs attributed to ibrutinib being diarrhea, infections and fatigue. Only 7 percent of patients irrespective of relationship experienced an AE leading to treatment discontinuation. Grade 3-4 hematological toxicities were infrequent, with neutropenia (16 percent), thrombocytopenia (11 percent) and anemia (10 percent) as the most frequent hematological AEs reported.

Data from this study were presented at the annual meeting of the American Society of Hematology in December 2012, the European Hematology Association annual meeting in June 2013 and are being presented at the 12th International Conference on Malignant Lymphoma in Lugano, Switzerland this week.

Study Design
The Phase 2, open-label, multicenter study was designed to determine the safety and efficacy of ibrutinib in patients with relapsed or refractory MCL. The primary endpoint of the study was overall response rate. Secondary endpoints included: duration of response, progression free survival, overall survival and frequency and severity of adverse events.

The study enrolled patients with a confirmed diagnosis of relapsed or refractory MCL at 18 s
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SOURCE Pharmacyclics, Inc.
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Related medicine technology :

1. Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
2. Updated Results of Two Phase 2 Ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma
3. Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
4. Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
5. Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor
6. Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
7. Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration
8. 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
9. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
10. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
11. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
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