Ofatumumab meets Phase III endpoint

Genmab (CSE:GEN) and GlaxoSmithKline (LSE:GSK; NYSE:GSK) said an interim analysis showed that ofatumumab met the primary endpoint of an objective response at 24 weeks in both groups of patients in an open-label Phase III trial to treat chronic lymphocytic leukemia (CLL). The interim analysis included 138 evaluable chronic CLL patients who either are refractory to fludarabine and alemtuzumab or are refractory to fludarabine and considered inappropriate candidates for alemtuzumab. The human antibody against CD20 achieved an objective response rate (ORR) of 51% (p<0.0001) in the former group of 59 patients, including 30 partial responses. The antibody achieved an ORR of 44% (p<0.0001) in the latter group of 79 patients, including one complete response and 34 partial responses. ...