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Positive Phase III Results for Obinutuzumab (GA101) in CLL Patients

Improved progression-free survival versus chlorambucil (Jan. 30)

Positive results have been reported from a phase III randomized, open-label trial that evaluated the efficacy and safety of the investigational drug obinutuzumab (GA101, Genentech) plus chlorambucil chemotherapy compared with chlorambucil alone in 800 patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab plus chlorambucil improved progression-free survival (PFS) by significantly reducing the risk of disease worsening or death compared with chlorambucil monotherapy.

Obinutuzumab is a glycoengineered, type 2 anti-CD20 monoclonal antibody for the treatment of hematological malignancies. The drug targets CD20 proteins found on B-cells, and is designed to cause cell death. The current standard of care for CD20-positive hematological malignancies is rituximab (Rituxan, Biogen Idec) in combination with chemotherapy or as a single agent. Obinutuzumab is being investigated in head-to-head clinical trials versus rituximab.

Hematological malignancies include CLL, indolent non-Hodgkin’s lymphoma (NHL), and diffuse large B-cell lymphoma (DLBCL). It has been estimated that NHL and CLL will cause approximately 19,020 and 4,580 deaths, respectively, in the U.S. in 2013.

Source: Genentech; January 30, 2013.

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