Genmab has 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 500mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu.
There were no unexpected safety findings reported during the treatment and within 30 days after last infusion. The most common adverse events of grade 3 or 4 (greater than 10%) were leucopenia and neutropenia. No events of sepsis or pneumonia were observed, and no deaths reported in the trial.
Lisa Drakeman, chief executive officer of Genmab, said: “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.”
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.