The results from the Phase III study of Arzerra (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, compared to those given bendamustine alone.
The safety profile observed in this study was consistent with that observed in other trials of ofatumumab and no new safety signals were observed.
“We are disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial. The completion of this Phase III study, which began in 2010, would not have been possible without the generous participation of the patients and their families, and we are most grateful for this. The full data will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The results from this Phase III study do not impact any other ongoing studies with ofatumumab, states the company.