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Phase III data shows Imbruvica (ibrutinib )superior to chlorambucil in chronic lymphocytic leukemia and small lymphocytic lymphoma - Janssen/Pharmacyclics

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Last updated:8th Dec 2015
Published:8th Dec 2015
Source: Pharmawand

Data from the investigational, randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) clinical trial show Imbruvica (ibrutinib), from Janssen/Pharmacyclics, was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older. Ibrutinib significantly prolonged progression-free survival (PFS), the study's primary endpoint, and overall survival (OS), a key secondary endpoint, and also improved other hematologic measures.

Notably, ibrutinib was associated with a 98 percent OS rate versus 85 percent for chlorambucil at 24 months. These data will be presented at the 2015 American Society of Hematology meeting and simultaneously published in The New England Journal of Medicine.

See: Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia

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