COMPLEMENT 1 study of Arzerra (ofatumumab)+ chlorambucil positive results published in The Lancet-Novartis

Phase III data published in The Lancet showed that treatment with Arzerra (ofatumumab), from Novartis, plus chlorambucil, a chemotherapy, resulted in a statistically significant improvement in progression free survival (PFS) versus chlorambucil alone in treatment-naïve patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy was considered inappropriate, mainly due to advanced age or the presence of comorbidities. The COMPLEMENT 1, (NCT00748189) trial included 447 patients with previously untreated CLL for whom fludarabine-based therapy was considered inappropriate, median PFS was improved by 71% in the group receiving ofatumumab plus chlorambucil compared to the chlorambucil alone group (22.4 months vs 13.1 months, respectively; HR 0.57 [95% CI 0.45, 0.72]; p<0.0001). Improvement in PFS was observed in most subgroups irrespective of age, gender, disease stage and prognostic factors. More patients in the group receiving ofatumumab plus chlorambucil (50%) experienced adverse events (AEs) of grade 3 or greater compared to chlorambucil alone (43%), with neutropenia being the most common adverse event (26% vs. 14%). Grade 3/4 infusion-related reactions (IRRs) were reported in 10% of patients receiving ofatumumab plus chlorambucil leading to drug withdrawal in 3% of patients and hospitalization in 2% of patients. No fatal IRRs were reported.

Comment: Arzerra was one of a portfolio of drugs sold by GSK to Novartis in 2014.

Comment: 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.