Date: 2014-06-27
Type of information: Results
phase: 3
Announcement: results
Company: GSK (UK) Genmab (Denmark)
Product: ofatumumab (Arzerra™)
Action
mechanism: Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. It is being developed under a co-development and commercialization agreement between Genmab and GSK. Ofatumumab is marketed under the trade name Arzerra® and is approved to treat chronic lymphocytic leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab in the US and EU as well as other territories.
Disease: bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This Phase III open-label study randomised 122 patients with bulky fludarabine-refractory CLL to one of two treatment arms. Patients were randomised to either ofatumumab or physicians\' choice (2:1). Patients randomised to ofatumumab received an initial dose of 300 mg, followed 1 week later by 2,000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2,000 mg every 4 weeks for a total treatment duration of 6 to 12 months. Patients in the physicians\' choice arm received a treatment regimen chosen by a physician for up to six months. The primary endpoint of the study was progression free survival as adjudicated by the Independent Review Committee. Secondary objectives are to evaluate response, overall survival, safety, tolerability and health-related quality of life of subjects treated with ofatumumab versus physicians\' choice of treatment.
Latest
news: * On June 27, 2014, GSK and Genmab announced that the Phase III study of ofatumumab (Arzerra™) versus physicians\' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL) did not meet its primary endpoint of progression free survival (PFS). The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians\' choice (Hazard Ratio 0.79, p=0.267). The result reported is headline data; the full analysis of safety and efficacy data is underway and will be completed in the coming months. This study (OMB114242) was conducted to meet the requirements from the EU Commission for the conditional approval of ofatumumab for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. The current indications in the EU or US do not include bulky fludarabine-refractory CLL patients. Based on this result, Genmab does not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population.
