Genmab A/S has initiated a phase III pivotal study with HuMax-CD20 (ofatumumab) to treat patients with refractory B-cell Chronic Lymphocytic Leukemia (CLL). HuMax-CD20 received a fast track designation from the FDA in December 2004 for this indication.
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.
"We are excited to begin the pivotal study for HuMax-CD20 in Chronic Lymphocytic Leukemia," said Lisa N. Drakeman, CEO of Genmab. "We hope HuMax-CD20 will become a new alternative to CLL patients who do not respond to currently available therapies," he added.
The objective of the study is to evaluate the efficacy and safety of HuMax-CD20 and the primary endpoint is objective response over a 24 weeks period from start of treatment. The responses will be assessed by an Independent Endpoints Review Committee according to the National Cancer Institute Working Group guidelines.