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Data Presented at American Society of Hematology from Ibrutinib Phase 1b/2 and Phase 2 Trials Suggest High and Durable Response in Chronic Lymphocytic Leukemia
Date:12/8/2012

r 65 years old, after a median follow up of 20.3 months
  • 71 percent in patients with RR disease, including patients with HR CLL/SLL, after a median follow up of 15.7 months
    • The estimated PFS at 26 months is 96 percent for patients over 65 years of age with TN CLL and 75 percent for those with RR/HR disease
      • Estimated OS at 26 months is 96 percent in TN patients and 83 percent in patients with RR/HR disease

    Responses were independent of high-risk clinical or genetic features, such as a deletion of part of chromosome 17 (del17p).

    Most adverse events (AEs) were Grade 1 or 2 in severity, with the most common attributed to ibrutinib being diarrhea, fatigue, nausea and rash. Adverse hematologic events were relatively infrequent. In patients with cytopenia (low blood cell counts) at the beginning of the study, sustained improvements of platelet counts (78 percent) and hemoglobin (82 percent) were seen after treatment. There was no evidence of cumulative toxicity or long-term safety concerns.

    Oral presentation 187, The BTK inhibitor ibrutinib (PCI-32765) in combination with rituximab is well tolerated and displays profound activity in high-risk chronic lymphocytic leukemia (CLL) patients
    Jan A. Burger, M.D., Ph.D., MD Anderson Cancer Center, Houston, TX

    This presentation was based on findings from a Phase 2, single-center trial with 40 patients with HR CLL treated with 420 mg/day ibrutinib in combination with rituximab, a current standard CLL therapy. Patients with HR disease were previously treated and had one of the following characteristics: deletion of a part of chromosome 17 (del17p), which is associated with poorer treatment outcomes; a gene mutation called TP53; del11q, another partial chromosome deletion associated with poorer outcomes; or a short remission duration (less than three years) after first-line chemo-
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    SOURCE Pharmacyclics, Inc.
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