Copenhagen, Denmark; December 13, 2007 – Genmab A/S
(OMX:GEN) announced today that 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.
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 initiation of alternative 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 6 month period from start of treatment.
About Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes
and represents 30% of non-Hodgkin’s lymphomas in adults and is the most
common lymphoid malignancy in the western world. There are an
estimated 63,000 new cases of DLBCL diagnosed in the per
year. The median age at diagnosis is about 65 years.