Novartis' Arzerra meets primary endpoint in CLL study

Swiss drug major Novartis (NOVN: VX) has announced top-line results from the Phase III COMPLEMENT 2 study showing that Arzerra (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival in patients with relapsed chronic lymphocytic leukemia (CLL).

CLL is the most commonly diagnosed adult leukemia in Western countries and accounts for around one in four cases of leukemia. The COMPLEMENT 2 study is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

Study results