Date: 2015-11-23
Type of information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: Genmab (Denmark)
Product: ofatumumab (Arzerra®)
Action
mechanism: monoclonal antibody. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug has been developed under a co-development and commercialization agreement between Genmab and GSK. In April 2014, Novartis has agreed to acquire GSK oncology products including ofatumumab.
Disease: follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial
details: This Phase III study aimed to randomize up to 516 patients to receive ofatumumab (1000 mg) or rituximab (375 mg/m2) by intravenous infusion for four weekly doses. Patients who had stable or responsive disease then received single infusions of ofatumumab or rituximab every two months for four additional doses for a total of eight doses over nine months. The primary endpoint of the study was progression free survival.
Latest
news: * On November 23, 2015, Genmab announced that the Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen will be stopped early. The decision to stop the study was made after a planned interim analysis performed by an Independent Data Monitoring Committee (IDMC) showed that it was unlikely that ofatumumab would show superiority if the trial was to be completed as planned.
