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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

creased 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.

Ibrutinib in Relapsed/Refractory DLBCL
In the second Phase 2 study involving patients with relapsed/refractory DLBCL (n=70), investigators tested the hypothesis that ibrutinib would be more active in the Activated B-cell-like (ABC) subtype compared to the Germinal Center B-cell-like (GCB) subtype, given that the ABC subtype is dependent on the B-cell antigen receptor (BCR) pathway. Ibrutinib targets the BCR pathway by inhibiting BTK, a critical mediator in malignant B-cell growth and proliferation. Results of the study show that:

  • Patients with the ABC subtype showed a significantly greater response to ibrutinib monotherapy compared to those with the GCB subtype (ORR = 41% vs 5%, p=0.007, Fisher's exact test).
  • Median OS was 9.76 months for
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SOURCE Janssen
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3. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
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