Date: 2013-05-29
Type of information: Results
phase: 3
Announcement: results
Company: Genmab (Denmark) GSK (UK)
Product: ofatumumab (Arzerra®)
Action
mechanism: monoclonal antibody. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug is being developed under a co-development and commercialization agreement between Genmab and GSK.
Disease: chronic lymphocytic leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The Phase III study COMPLEMENT 1 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. The primary endpoint of the study was PFS according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines, using an independent endpoints review committee. (NCT00748189)
Latest
news: * On May 29, 2013, Genmab and GSK have 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. The study results, including secondary endpoints,will be submitted to the International Workshop on CLL (iwCLL) in Cologne this September. Regulatory submissions in the EU, US, and other regions are also planned in the coming months.
