Genmab starts phase III HUMAX study in leukaemia patients
Genmab of Denmark has begun a Phase III study with HuMax-CD20 (ofatumumab) to treat patients with refractory B-cell Chronic Lymphocytic Leukaemia (CLL). HuMax-CD20 received a Fast Track designation from the FDA in December 2004 for this indication.
Genmab of Denmark has begun a Phase III study with HuMax-CD20 (ofatumumab) to treat patients with refractory B-cell Chronic Lymphocytic Leukaemia (CLL). HuMax-CD20 received a Fast Track designation from the FDA in December 2004 for this indication.
The international biotech company headquartered in Copenhagen has planned a study that will include 100 CLL patients who have failed treatment with fludarabine and alemtuzumab or who have failed fludarabine and are intolerant to or ineligible for alemtuzumab.
The objective of the study is to evaluate the efficacy and safety of HuMax-CD20 and the primary end-point is objective response over a 24 weeks period from start of treatment. Patients in the single arm trial will receive eight weekly infusions of HuMax-CD20, followed by four monthly infusions of HuMax-CD20. Disease status will be assessed every four weeks until week 28 and then every three months until disease progression or month 24.
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. Genmab ceo Lisa Drakeman, said: "We hope HuMax-CD20 will become a new alternative to CLL patients who do not respond to currently available therapies."