GENMAB ANNOUNCES POSITIVE TOP-LINE RESULTS FOR ARZERRATM IN FRONT LINE NHL
Copenhagen, Denmark; August 26, 2009 - Genmab A/S (OMX: GEN) announced today positive top-line results from the Phase II study of ArzerraTM (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 3 or 4 (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, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
About the study
Patients in this open label study were randomized into two dose groups of 29 patients each. Patients were to receive 300 mg of ofatumumab at the first infusion, followed by 5 infusions of either 500 or 1000 mg of ofatumumab every 3 weeks in combination with 6 cycles of CHOP. Disease status is measured prior to the fourth cycle, at three months following the last treatment and then every three months until month 12, and every six months thereafter until 24 months or initiation of alternative treatment. Treatment response was assessed according to the 1999 standardized response criteria for NHL by an Independent endpoints Review Committee.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study was objective response from start of treatment until 3 months after last administration of ofatumumab.
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. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.