Genmab's HuMax-CD20 enters pivotal Ph III trial

Copenhagen, Denmark-based drugmaker Genmab AS has initiated a Phase III pivotal study with its anticancer drug candidate HuMax-CD20 (ofatumumab) in refractory B-cell chronic lymphocytic leukemia.

The agent received a fast-track designation from the US Food and Drug Administration in December 2004 for this indication and the study will include approximately 100 CLL patients who have failed treatment with fludarabine and alemtuzumab or who have failed fludarabine and are intolerant to or ineligible for alemtuzumab.

Patients in the single arm trial will receive eight weekly followed by four monthly infusions of HuMax-CD20 in doses of 300mg and 2,000mg, respectively. Disease status will be assessed every four weeks until week 28 and then every three months until disease progression or month 24. The objective of the study is to evaluate the efficacy and safety of HuMax-CD20 and the primary endpoint is objective response over 24 weeks from the start of treatment.