Ofatumumab, a human monoclonal antibody for lymphoid malignancies and autoimmune disorders

Genmab A/S and licensee GlaxoSmithKline plc are developing ofatumumab, an anti-CD20 human mAb, for the potential intravenous treatment of non-Hodgkin's lymphoma and autoimmune diseases, such as rheumatoid arthritis (RA) and multiple sclerosis (MS). Phase I and II clinical trials have been completed in patients with chronic lymphocytic leukemia (CLL), rituximab-refractory follicular lymphoma (FL) and RA. At the time of publication ofatumumab was undergoing a phase II clinical trial in patients with diffuse large B-cell lymphoma and phase III clinical trials in patients with B-cell CLL (B-CLL) in which fludarabine and alemtuzumab treatments have failed and in patients with rituximab-refractory FL. Ofatumumab was also undergoing phase II clinical trials as a combination therapy for previously untreated patients with FL in combination with cyclophosphamide, adriamycin, vincristine, and prednisone and in combination with fludarabine and cyclophosphamide for the treatment of B-CLL. In addition, two phase III clinical trials to assess patients who have an inadequate response to methotrexate and TNFalpha therapy were ongoing for patients with RA, and a phase II clinical trial to investigate the effects of repeated doses of ofatumumab was recruiting patients with RA from a previous trial on ofatumumab. A phase I/II clinical trial of ofatumumab in relapsing-remitting MS was expected to commence in 2008.