Arzerra ofatumumab: Phase III started

Genmab began an open-label Phase III trial to compare 4 weekly doses of 1,000 mg IV ofatumumab vs. 375 mg/m 2 rituximab in about 516 follicular NHL patients that relapsed at least 6 months after completion of a rituximab-containing regimen. Patients with stable or responsive disease will then receive single infusions of ofatumumab or rituximab every 2 months over 9 months.

GSK has worldwide co-development and commercialization rights to ofatumumab from Genmab under a 2006 deal, which was amended in July to grant the pharma full responsibility for developing the compound in autoimmune indications (see BioCentury, July 5). GSK markets ofatumumab as Arzerra in the U.S. and EU to treat chronic lymphocytic leukemia (CLL). ...