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news.Study demonstrates the activity of ofatumumab in patients who had not responded to prior treatment with a CD20 antibody
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GlaxoSmithKline (GSK) and Genmab have provided top-line results from an international multi-center study of Arzerra (ofatumumab) in rituximab refractory follicular non-Hodgkin’s lymphoma (NHL).
Reportedly, a total of 116 patients were treated in the study, including 30 patients treated with 500mg ofatumumab and 86 patients treated with 1000mg of ofatumumab.
The primary endpoint was objective response (International Working Group Criteria) over six months from the start of treatment, in the 1000mg dose population.
The overall response rate (ORR) in the 1000mg treatment arm was 10%, including one complete response and 8 partial responses. In addition, 50% of patients in the 1000mg treatment arm had stable disease. The overall response rate in the total population was 11%.
Additionally, the ORR among patients who were refractory to prior rituximab monotherapy was 22%. For patients considered refractory to rituximab in combination with chemotherapy, the response rate was 7%, and among patients considered refractory to rituximab maintenance, the response rate was 9%.
The median duration of response in the 1000mg treatment arm was 6 months and the progression free survival was six months.
Lisa Drakeman, CEO of Genmab, said: “The results of this study demonstrate the activity of ofatumumab in patients who had not responded to prior treatment with a CD20 antibody. The response rate in patients refractory to rituximab monotherapy is of interest and warrants further study. We are committed to the further development of ofatumumab in NHL.