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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

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) 18 th 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 MCLIn 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 decreased appetite (21%) and were consistent with previously reported data. Only 7% of patients discontinued due to an AE.

"The results of this single-agent study are encouraging. It is exciting to see how active ibrutinib is in the treatment of relapsed and refractory mantle cell lymphoma, particularly as the responses appear to last.," said Professor Simon Rule, Consultant Haematologist in the Department of Haematology at the Derriford Hospital in Plymouth, United Kingdom. "What is equally important is that no new safety signals were observed during this study."

The MCL study was a Phase 2 multicenter, open-label, study including 111 patients with relapsed/refractory MCL at 18 sites internationally. Patients had received a median of three prior therapies and were enrolled into two cohorts based on prior bortezomib exposure – either bortezomib-naive (n=63) or bortezomib-exposed (n=48), with both groups receiving 560 mg of ibrutinib orally, once a day. The primary endpoint of the study was ORR. Secondary endpoints included DOR, PFS, OS and frequency and severity of adverse events.

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