Genmab A/S announced positive top-line results from the phase-II study of Arzerra (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin's lymphoma (NHL).
A total of 58 patients were treated in the study. The overall response rate (ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse events of grade three or four (greater than 10 percent) were leucopenia and neutropenia. No events of sepsis or pneumonia were observed, and no deaths reported in the trial.
"We are pleased with the positive results shown in this study and believe they are indicative of the potential of ofatumumab in the treatment of front line follicular non-Hodgkin's lymphoma," said Lisa N Drakeman, chief executive officer of Genmab.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
Ofatumumab is an investigational, fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane.