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Date: 2010-08-10
Phase: II
Anouncement: Result
Biotech: Genmab (Denmark)
Product: Arzerra® (ofatumumab)
Disease: relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Other: Genmab announced 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, 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. 96% of the patients in the study had received prior rituximab therapy. 44% of the patients received between two and five prior courses of rituximab. 31% of patients had received a prior stem cell transplant and the remaining 69% were ineligible for transplant. The objective response rate observed at the interim analysis was 11% with a median duration of response of 6.9 months.
These results indicates the need to combine CD20 agents with cytotoxic chemotherapeutic agents in further investigations of CD20 therapy in such heavily pretreated DLBCL patient populations.
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%).