Genmab announces the start of a Phase III head to head study of ofatumumab versus rituximab in follicular NHL.
Genmab A/S (Copenhagen:GEN) announced today the start of a Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen to which they responded.
Approximately 516 patients in this open-label study will be randomized to receive ofatumumab (1000 mg) or rituximab (375 mg/m2) by intravenous infusion for four weekly doses. 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. The primary endpoint of the study is progression free survival.