Arzerra (ofatumumab) meets primary endpoint in Phase III trial in CLL- Novartis

Novartis 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. COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL.

Comment: Arzerra was one of a portfolio of drugs sold by GSK to Novartis in 2014. Meanwhile Imbruvica (ibrutinib) from Janssen Biotech in the RESONATE study of relapsed CLL patients demonstrated superiority over Arzerra and provided 88% PFS at 6 months and a 50% reduction in deaths at 9 months.