Genmab to stop ofatumumab Phase III study in follicular NHL deemed unlikely to show superiority

Denmark’s Genmab (OMX: GEN) revealed yesterday 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 six 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. No new safety signals for ofatumumab were identified

“The outcome of the interim analysis in this study is disappointing as we had hoped to see superiority of ofatumumab. The data from the study will now be prepared so that it can be presented at a future scientific conference,” said Jan van de Winkel, chief executive of Genmab.