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Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
Date:6/16/2013

RARITAN, N.J., June 16, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen), today announced the results of two separate Phase 2 studies suggesting that ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, shows efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL). The studies were presented today at the European Hematology Association (EHA) 18th Annual Congress in Stockholm, Sweden. Ibrutinib is being jointly developed by Janssen and Pharmacyclics, Inc.

"Our comprehensive clinical development program is studying ibrutinib across a variety of B-cell malignancies; these patients, including those with DLBCL and MCL, are in real need of new treatment options," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen R&D. "It's particularly exciting to observe the differences in response rates now as compared to earlier data from this study that were presented several months ago."

Ibrutinib in Relapsed/Refractory MCL
In relapsed/refractory MCL patients treated with ibrutinib monotherapy the key results include:

  • An overall response rate (ORR) of 68%, including a complete response (CR) of 21% and a partial response (PR) of 47%.
  • The estimated median duration of response (DOR) in all responding patients was 17.5 months. Median progression-free survival (PFS) was 13.9 months. Median overall survival (OS) has not yet been reached, but is estimated to be 58% at 18 months.
  • Treatment-emergent adverse events (AEs) were seen in greater than 20% of patients and included diarrhea (50%), fatigue (41%), nausea (31%), peripheral edema (28%), dyspnea (27%), constipation (25%), upper respiratory tract infection (23%), vomiting (23%) and de
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SOURCE Janssen
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Related medicine technology :

1. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
2. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
3. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
4. 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
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7. Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor
8. Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
9. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
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