Genmab announces preliminary top-line results for Arzerra in front line CLL
Genmab A/S announced top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events, was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
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Topic world Antibodies
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