Genmab announces start of ofatumumab Phase III head to head study

12-Nov-2009 - Denmark

Genmab A/S announced the initiation of a Phase III study of Arzerra™ ofatumumab plus chemotherapy versus rituximab plus chemotherapy to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

“The start of this study marks an important milestone in the development of ofatumumab. It is the first head to head study of ofatumumab against another CD20 antibody,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

The study will include 380 patients who are refractory to or have relapsed following first line treatment with rituximab in combination with a chemotherapy regimen containing anthracycline and are eligible for autologous stem cell transplant (ASCT). Patients in the study will be randomized to receive three cycles of either ofatumumab or rituximab in addition to chemotherapy. After the third treatment cycle patients who obtain a complete or partial response will receive high dose chemotherapy followed by ASCT. The primary endpoint of the study is progression free survival.

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