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 leukaemia (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 per cent in patients who received 500 mg of ofatumumab (n=31) and 50 per cent in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77 per cent in the 500 mg treatment group and 73 per cent 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 per cent. 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.
"We are pleased to see the positive results of this first study investigating ofatumumab for the treatment of front line CLL," said Lisa N Drakeman, chief executive officer of Genmab. "We look forward to presenting the full data at a future medical meeting."
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.