132 patients enter pivotal study of Genmab CLL drug

Danish drugmaker Genmab AS has completed recruitment in a pivotal study of ofatumumab (HuMax-CD20) for the treatment of refractory chronic lymphocytic leukemia. This 132-patient cohort comprises 66 patients who are refractory to both fludarabine and alemtuzumab and 66 fludarabine refractory patients who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. An interim analysis will be conducted on this cohort when 24-week efficacy data are available. The study will remain open for recruitment in order to collect additional safety and efficacy data, the firm noted.

Ofatumumab is an investigational, fully-human, next-generation monoclonal antibody being jointly developed with UK drug major GlaxoSmithKline that targets a unique epitope of the CD20 receptor on the surface of B lymphocytes. This epitope is different to the other anti-CD20 antibodies currently available or in development, the firm noted.

"It is our hope, due to the high unmet need amongst these patients, that registration may be possible in each indication, depending on the data generated and ongoing discussions with the regulatory authorities. Recruitment will continue to the trial," said Lisa Drakeman, chief executive of Genmab. The study includes CLL patients who are refractory to both fludarabine and alemtuzumab and patients who are refractory to fludarabine and are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes.