The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively. A high rate (61%) of treatment with next-line therapies in both the treatment arms may dilute any potential OS difference and confound the interpretation of the OS results. Addition of ofatumumab to chlorambucil demonstrated clinical benefit and tolerability as a frontline treatment option in patients unfit for fludarabine-containing therapy, with no new safety concerns.

Department of Haematology Medical University of Lodz Lodz Poland

Department of Haematology Niguarda Cancer Center Niguarda Hospital Milan Italy

Department of Haematology St James's University Hospital Leeds UK

Department of Hematology Medical University of Bialystok Bialystok Poland

Department of Hematology University Hospital Ghent Gent Belgium

Department of Internal Medicine Haematology and Oncology Masaryk University Hospital Brno Brno Czech Republic

Department of Medical Oncology Kidwai Memorial Institute of Oncology HCG Hospitals Bangalore India

Department of Oncology University of Oxford Oxford UK

Haematology Department Department of Internal Medicine University of Athens Laikon General Hospital National and Kapodistrian University of Athens Medical School Athens Greece

Medical University of Silesia Katowice Poland

Novartis Pharma AG Basel Switzerland

Novartis Pharma S A S Paris France

Universitaire Ziekenhuizen Leuven Leuven Belgium

University of Liverpool Liverpool UK

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