Genmab Announces Phase III Study of Arzerra® Met Primary Endpoint of Improved Progression-Free Survival in Patients with Relapsed CLL

29-Apr-2015 - Denmark

Genmab A/S announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra® (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (p = 0.0036) compared to those given fludarabine and cyclophosphamide alone. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.

“We are pleased with the positive topline results in this pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL.  This outcome is good news for patients with CLL, a disease for which relapses are inevitable.  We look forward to sharing additional data from the study at an upcoming medical conference and to discussions with the regulatory authorities in collaboration with Novartis,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

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