Genmab : Phase III Study Of Arzerra Met Primary Endpoint Of Improved PFS

(RTTNews) - Genmab A/S (GNMSF.PK) announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra(r) (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival or 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.

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.