Genmab 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)
Copenhagen, Denmark | November 9, 2009 | Genmab A/S (OMX: GEN) announced today 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.
About ofatumumab
Ofatumumab is an investigational, fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in any country for DLBCL.
SOURCE: Genmab
Post Views: 62
Genmab 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)
Copenhagen, Denmark | November 9, 2009 | Genmab A/S (OMX: GEN) announced today 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.
About ofatumumab
Ofatumumab is an investigational, fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in any country for DLBCL.
SOURCE: Genmab
Post Views: 62
