Genmab A/S (OMX: GEN) announced today top-line interim results from an initial Phase II single arm open label study
of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell
Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell
transplant.
The objective of the study was to determine the efficacy of ofatumumab in
patients with relapsed DLBCL ineligible for transplant or relapsed after
transplant. The primary endpoint of the study was objective response rate
(ORR), as determined by an Independent Review Committee, over a six month period
from start of treatment. A total of 81 patients were treated in the study.
Ninety-six percent of the patients in the study had received prior rituximab
therapy. Fifty-four percent of the patients received between two and five prior
courses of rituximab. Thirty-one percent of patients had received a prior stem
cell transplant and the remaining 69% were ineligible for transplant. The
objective response rate (ORR) observed at the interim analysis was 11% with a
median duration of response of 6.9 months.
There were no unexpected safety findings. The most common adverse events (>10%
of patients) occurring in patients treated with ofatumumab were infections
(37%), diarrhea (17%), fatigue (15%), peripheral edema (15%), neutropenia (14%),
abdominal pain (12%), constipation (12%), nausea (12%), pyrexia (11%), anemia
(11%) and leukopenia (11%).
"The response rate observed in this study points to the need to combine CD20
agents with cytotoxic chemotherapeutic agents in further investigations of CD20
therapy in such heavily pretreated DLBCL patient populations," said Prof. Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab.
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.
About ofatumumab
Ofatumumab is a human monoclonal antibody. Ofatumumab is not approved in any
country for treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL).
Source: Genmab A/S