Genmab A/S has announced that interim results in the HuMax-CD20 Phase I/II study to treat chronic lymphocytic leukaemia (CLL) will be presented at the 11th International Workshop on Chronic Lymphocytic Leukaemia in New York City, New York. The data will be presented at the University of Lyon in France on September 16, 2005.
The study is an open-label dose escalation trial that enrolled 33 patients with CLL who had failed previous therapy. The trial has three dose levels. Three patients at the first dose level received an initial dose of 100 mg followed by three weekly doses of 500 mg, at the second dose level three patients received a dose of 300 mg followed by three weekly doses of 1000 mg and at the third level 27 patients received an initial dose of 500 mg followed by three weekly doses of 2000 mg.
The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19.
HuMax-CD20 received a Fast Track designation from the US Food and Drug Administration in December 2004 for Genmab’s CLL development program.
CLL is the most common leukaemia in adults in the US and most of Western Europe. The incidence is 8,100 to 12,500 new cases in the US per year and 85-95% of the cases are of B-cell origin. CLL is a subgroup of non-Hodgkin’s lymphoma (NHL) and together with small lymphocytic lymphoma (SLL) corresponds to around 20% of all NHL cases.