GlaxoSmithKline (GSK) and Genmab A/S informed that they have started a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within six months of a rituximab containing regimen. Under the terms of Genmab’s collaboration with GSK, Genmab will receive a milestone payment of approximately DKK 116 million (approximately $ 20 million), triggered by the treatment of the first patient in the study.

A total of 338 patients in this open label study will be randomised to receive either ofatumumab in addition to bendamustine or bendamustine alone. The primary endpoint of the study is progression free survival. Patients in the bendamustine monotherapy group will have the opportunity to receive ofatumumab if their lymphoma progresses.

Ofatumumab is a human monoclonal antibody which targets CD20. Ofatumumab is not approved in any country for indolent B-cell non-Hodgkin’s lymphoma (B-NHL). More than one-third of lymphoma patients have indolent B-cell non-Hodgkin’s lymphoma, which includes follicular lymphoma and other typically slow growing lymphomas which initially respond to treatment but relapse with time.1 Indolent B-NHL is defined by expression of the CD20 molecule, which is the target of monoclonal antibodies such as rituximab and ofatumumab.