BioCentury
ARTICLE | Clinical News

First-line Arzerra meets in Phase III CLL trial

May 30, 2013 12:13 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Genmab A/S (CSE:GEN) said first-line treatment with IV Arzerra ofatumumab plus chlorambucil chemotherapy met the primary endpoint in the Phase III COMPLEMENT-1 trial to treat chronic lymphocytic leukemia (CLL). Specifically, Arzerra plus chlorambucil improved median progression-free survival (PFS) vs. chlorambucil alone (22.4 vs. 13.1 months, p<0.001). The open-label, international trial enrolled 447 patients with previously untreated CLL considered inappropriate for fludarabine-based therapy. GSK said it plans to submit regulatory applications for Arzerra as first-line treatment of CLL in the U.S., EU and "other regions in the coming months," but the pharma declined to disclose details. ...