Arzerra ofatumumab: Updated Phase III data

Updated data from an open-label Phase III trial in 95 patients refractory to fludarabine and alemtuzumab showed that ofatumumab produced an objective response rate (ORR) of 51%. Genmab said the data from the completed trial are consistent with the efficacy and safety data reported in a 2008 interim analysis, which formed the basis for FDA's accelerated approval last year of the drug to treat CLL refractory to fludarabine and alemtuzumab. In the interim analysis, ofatumumab produced an ORR of 51% in 59 evaluable patients, which met the primary endpoint (see BioCentury, Aug. 4, 2008 & Dec. 22, 2008). The trial also enrolled 128 patients who were not refractory to both fludarabine and alemtuzumab. ...