Arzerra ofatumumab: Phase II data

In a double-blind, dose-escalation, crossover Phase II trial in 26 patients initially treated with IV ofatumumab for 24 weeks and then crossed over to placebo, repeated MRI scans showed a sustained reduction in the number of brain lesions up to week 48. Additionally, the 12 subjects who received placebo for the first 24 weeks and then crossed over to treatment with IV ofatumumab had similar results as those initially treated with ofatumumab. Subjects received 2 infusions of 100, 300 or 700 mg ofatumumab or placebo.

Genmab previously reported interim data showing that IV ofatumumab met the secondary efficacy endpoint of significantly reducing the number of gadolinium-enhancing T1 and new or enlarging T2 brain lesions as measured by serial MRI scans from week 8 to week 24 vs. placebo (see BioCentury, July 12). In July, Genmab amended a 2006 deal with GlaxoSmithKline to give the pharma full responsibility for development of ofatumumab in autoimmune indications (see BioCentury, July 5). GSK markets ofatumumab as Arzerra in the U.S. and EU to treat chronic lymphocytic leukemia (CLL). ...