BioCentury
ARTICLE | Clinical News

Arzerra misses in Phase III bulky fludarabine-refractory CLL

June 27, 2014 11:50 PM UTC

Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Arzerra ofatumumab missed the primary endpoint of improving median progression-free survival (PFS) vs. physicians' choice of treatment in the Phase III OMB114242 trial to treat bulky fludarabine-refractory chronic lymphocytic leukemia (CLL) (5.36 vs. 3.62 months, p=0.267). The open-label, European trial enrolled 122 patients with fludarabine-refractory CLL with bulky lymphadenopathy, defined as at least one lymph node of 5 cm or greater. GSK said it expects to complete a full analysis of the data "in the coming months" and submit the final analysis to the European Commission. The pharma conducted the trial to meet a requirement under the EC's conditional approval of Arzerra to treat CLL in patients who are refractory to fludarabine and alemtuzumab.

GSK markets Arzerra in the U.S. and EU to treat CLL refractory to fludarabine and alemtuzumab and in the U.S. as first-line treatment of CLL. The pharma has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab, which was up DKK2.30 to DKK236.80 on Friday. The data were released after market close in Denmark. ...