Genmab Initiates Ofatumumab Study In Diffuse Large B-Cell Lymphoma

Armen Hareyan's picture
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Genmab's study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.

Approximately 75 patients will be enrolled in the study which is being conducted under Genmab's collaboration with GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately DKK 87.2 million from GSK upon treatment of the first patient in the study, expected in the near future.

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Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

"We have now expanded the ofatumumab clinical development program into a fourth disease area," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL."

About the trial

In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of 24 months after treatment start according to the "Revised response criteria for malignant lymphoma." After 24 months, patients will be followed until

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