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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

the ABC subtype, compared to 3.35 months for the GCB subtype (p=0.05).
  • Within the ABC subtype group, only patients who had a CD79B mutation responded to treatment; patients with only an MYD88 mutation did not respond to treatment, suggesting a MYD88-dependent but BCR-independent pathogenesis for some DLBCL tumors.
  • Safety data from 70 patients identified no new safety signals. Grade 3 or higher AEs were seen in greater than 3% of patients and included fatigue (9%), hyponatremia (9%), pneumonia (7%), dehydration (4%), and pleural effusion (4%).
  • "These results indicate the important function BTK plays in the survival of ABC type DLBCL," explained presenting investigator Sven de Vos, M.D., Ph.D., Associate Professor in the Department of Medicine at the UCLA Medical Center, Los Angeles, who reported the results at the EHA Congress today. "Seeing clinically meaningful responses among the ABC subtype was encouraging, as patients at this stage are challenging to treat. Additional trials among this patient group are ongoing."

    The DLBCL study was a Phase 2 multicenter, open-label, study that included 70 patients with relapsed/refractory DLBCL with a median of three prior therapies. All patients underwent gene expression profiling to determine their DLBCL subtype, 29 patients were identified with the ABC subtype, and 20 with the GCB subtype. Patients received ibrutinib 560 mg orally, once a day, until disease progression or unacceptable toxicity. The primary objective of the study was to assess ORR categorized by subtype, with secondary objectives being to assess the safety and tolerability of ibrutinib in people with DLBCL.

    About Ibrutinib
    Ibrutinib is an investigational, oral BTK inhibitor. The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies.

    Janssen Biotech, Inc. and Pharmac
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