Ofatumumab sees positive Ph III CLL data

Danish biotechnology firm Genmab and UK drug major GlaxoSmithKline have reported positive top-line results from an interim analysis of the Phase III pivotal study evaluating ofatumumab (HuMax-CD20) to treat two groups of chronic lymphocytic leukemia patients with high unmet medical need.

At the interim analysis, the 154-patient study met the primary endpoint in both populations and the results from the secondary endpoints also support the primary endpoint, the firms noted. An objective response rate of 51% consisting of 30 partial responses was achieved in the group of patients refractory to fludarabine/alemtuzumab (p<0.0001). In the fludarabine refractory, alemtuzumab-inappropriate patient group, an objective response rate of 44% (p<0.0001) was achieved, including one complete response, and 34 partial.

Achievement of the reported objective response rates are based on evaluations by an independent committee and are subject to review and confirmation by the regulatory authorities, the firm noted.