Phase III trial of Arzerra fails to meet primary endpoint in CLL-GSK/Genmab

GlaxoSmithKline and Genmab announced that the Phase III study of Arzerra (ofatumumab) versus physicians� choice in patients with bulky fludarabine-refractory Chronic Lymphocytic Leukaemia (CLL) did not meet its primary endpoint of progression free survival (PFS). The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians� choice (Hazard Ratio 0.79, p=0.267). The result reported is headline data; the full analysis of safety and efficacy data is underway and will be completed in the coming months.

This study (OMB114242) was conducted to meet the requirements from the EU Commission for the conditional approval of ofatumumab for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. The current indications in the EU or US do not include bulky fludarabine-refractory CLL patients. The drug was approved in the US in April 2014.