Arzerra fails to meet primary endpoint in phase III COMPLEMENT A+B study in indolent B-cell non-Hodgkin's lymphoma.- Genmab.

Genmab announced that topline 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. The full data will be submitted for publication at a future medical conference. The results from this Phase III study do not impact any other ongoing studies with ofatumumab.

The COMPLEMENT A+B study is an open-label, two-arm, randomized, Phase III study that included 346 patients with indolent B-cell non-Hodgkin's lymphoma who were unresponsive to rituximab or a rituximab-containing regimen. Patients in the study were randomized 1:1 to treatment with up to eight cycles of bendamustine given in combination with 12 doses of ofatumumab (1,000 mg) or up to eight cycles with bendamustine alone. The primary endpoint of the study was PFS. fatumumab is not approved for the treatment of indolent non-Hodgkin’s Lymphoma.