Novartis says leukaemia drug Arzerra meets main goal in trial

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The FINANCIAL — Novartis on April 27 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 chronic lymphocytic leukemia (CLL) (p=0.0036).

The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed, according to Novartis.

“Patients eventually stop responding to current CLL treatments, making the investigation of new options critically important,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. “We’re encouraged by these positive topline results from COMPLEMENT 2, which demonstrate continued momentum for our expanding oncology portfolio and we look forward to sharing the full results of this study at an upcoming medical meeting.”

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia.


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