Glaxo (GSK +0.2%) and Genmab's Arzerra (ofatumumab) fails to meet its primary endpoint of a statistically significant improvement in progression-free survival (PFS) versus physicians' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukemia (CLL). The median PFS for the ofatumumab cohort was 5.36 months compared to 3.61 months in the physicians' choice group. The companies sponsored the 122-patient Phase 3 study as a means to expand Arzerra's label in refractory CLL.
Genmab CEO Jan van de Winkel, Ph.D., says, "Although ofatumumab performed broadly in-line with previous data, today's result is disappointing. Based on this result, we do not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population."