In this open label trial, each patient will receive eight weekly infusions of ofatumumab. The first infusion will be 300mg and the seven subsequent infusions will be 1000mg of ofatumumab. Disease status will be assessed four weeks after the last infusion and then every three 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 initiation of alternative diffuse large B-Cell lymphoma (DLBCL) treatment or month 60. The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a six month period from start of treatment.
Approximately 75 patients will be enrolled in the study which is being conducted under Genmab’s collaboration with GlaxoSmithKline. Genmab will receive a milestone payment of approximately DKK87.2 million from GSK upon treatment of the first patient in the study, expected in the near future. 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.
Lisa Drakeman, CEO of Genmab, said: “We have now expanded the ofatumumab clinical development program into a fourth disease area. We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL.”