Ofatumumab: a novel, fully human anti-CD20 monoclonal antibody for the treatment of chronic lymphocytic leukemia.

ABSTRACT

Ofatumumab is a fully human, IgG anti-CD20 monoclonal antibody codeveloped by GlaxoSmithKline (Brentford, UK) and Genmab (Copenhagen, Denmark). In preclinical studies, ofatumumab exhibited more potent in vitro activity than rituximab against B-cell malignancies and prolonged survival in in vivo animal models compared with rituximab. Ofatumumab is clinically well tolerated with initial infusion reactions being the predominant associated toxicity. Ofatumumab has demonstrated efficacy in relapsed/refractory chronic lymphocytic leukemia (CLL) and has received regulatory approval in both Europe and the USA for treatment of fludarabine and alemtuzumab refractory disease. Single-agent ofatumumab has resulted in overall response rates of 42-51% in relapsed/refractory CLL and up to 80% when combined with chemotherapy. In de novo CLL, overall response rates of 77-78% have been achieved.