Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20 molecule on B-cells encompassing an epitope on the small and large loops.
In the open-label study, approximately 516 patients are expected to be randomised to receive Ofatumumab (1000mg) or Rituximab (375mg/m2) by intravenous infusion for four weekly doses.
Additionally, patients who have stable or responsive disease will then receive single infusions of Ofatumumab or Rituximab every two months for four additional doses for a total of eight doses over nine months.
Genmab said that the primary endpoint of the study is progression free survival.
Ofatumumab is not approved in any country for indolent B-cell non-Hodgkin’s lymphoma (B-NHL).