Genmab Initiates Phase III Study For Ofatumumab

Genmab has initiated 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 study is expected to 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).

Reportedly, in the study the patients will be randomised 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.

Lisa Drakeman, CEO of Genmab, said: “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.”