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ARTICLE | Clinical News

Arzerra ofatumumab: Additional Phase III data

June 22, 2015 7:00 AM UTC

Additional data from the open-label, international Phase III COMPLEMENT 2 trial in 365 patients with relapsed CLL showed that IV Arzerra plus fludarabine and cyclophosphamide led to a median PFS, the primary endpoint, of 28.9 months vs. 18.8 months for fludarabine and cyclophosphamide alone (HR=0.67, 95% CI: 0.51, 0.88, p=0.0032). Arzerra plus fludarabine and cyclophosphamide also met the secondary endpoints of improving ORR (84% vs. 68%, p=0.0003) and time to progression (42.1 vs. 26.6 months, HR=0.63, 95% CI: 0.45, 0.87, p=0.0036) vs. fludarabine and cyclophosphamide alone. At a median follow-up of 34 months, Arzerra plus fludarabine and cyclophosphamide led to a median OS of 56.4 months vs. 45.8 months for fludarabine and cyclophosphamide alone (HR=0.78, 95% CI: 0.56, 1.09, p=0.141). Additionally, Arzerra plus fludarabine and cyclophosphamide led to a duration of response of 29.6 months vs. 24.9 months for fludarabine and cyclophosphamide alone (HR= 0.77, 95% CI: 0.56, 1.05, p=0.0878). Data were presented at the European Hematology Association meeting in Vienna. ...