Glaxosmithkline Plc and Genmab A/S Announce Positive Top-Line Results From Pivotal Study of ARZERRA Combined With Chlorambucil in Previously Untreated Chronic Lymphocytic Leukemia


Wednesday, 29 May 2013 01:16pm EDT 

Genmab A/S and Glaxosmithkline Plc announced that their Phase III study of ARZERRA (ofatumumab) in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL) met its primary endpoint of progression free survival (PFS) as assessed by an Independent Review Committee (IRC). A total of 447 patients were enrolled in the study. A 9.3 month improvement in the time a patient lived without worsening of their disease (median PFS) was seen in patients randomized to ofatumumab and chlorambucil compared to patients randomized to chlorambucil alone (22.4 months vs. 13.1 months; Hazard Ratio 0.57; p <0.001). There were no unexpected safety findings. The most common (>=1%) serious adverse events as reported by the investigator within 60 days of last treatment were neutropenia [including febrile neutropenia] (5%), anaemia (4%), pneumonia (4%), and pyrexia (2%). Infusion reactions were mild to moderate in severity with 3% of infusion reactions reported as serious. This Phase III study (NCT00748189) included patients with previously untreated CLL considered inappropriate for fludarabine-based therapy. Patients in the study were randomized 1:1 to treatment with up to twelve cycles of ofatumumab in combination with chlorambucil or up to twelve cycles of chlorambucil alone. 

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