Genmab starts Humax-Cd20 pivotal study in non-Hodgkin's lymphoma

By E. Janene Geiss

Philadelphia, July 10 - Genmab AS said Monday it has begun a pivotal study to treat follicular non-Hodgkin's lymphoma patients who are refractory to rituximab.

The study will include about 162 non-Hodgkin's lymphoma patients who are refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment, according to a company news release.

"[Non-Hodgkin's lymphoma] is the second indication to enter a pivotal study for HuMax-CD20," Lisa N. Drakeman, chief executive officer of Genmab, said in the release. "We now have two possible pathways to initial approval for HuMax-CD20 targeting two different disease indications."

Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by seven weekly infusions of either 500 or 1,000 mg of HuMax-CD20.

Disease status will be assessed every three months for 24 months, officials said.

The objective of the study is to determine the efficacy and safety of two dose regimens of HuMax-CD20. The primary endpoint of the study is objective response as measured over a six-month period from start of treatment assessed by an independent endpoints review committee according to the standardized response criteria for non-Hodgkin's lymphomas.

Humax-Cd20 is also being studied for patients with active rheumatoid arthritis.

Genmab is a Copenhagen, Denmark, biotechnology company that develops human antibodies.

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