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A five‐year follow‐up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: Final analysis of the complement 1 phase 3 trial

British Journal of Haematology Apr 06, 2020

Offner F, Robak T, Janssens A, et al. - Researchers designed a complement 1 trial to evaluate the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia. An estimated 12% (not significant) and 39% risk reduction were noted in overall survival and progression‐free survival, respectively on long‐term follow‐up in the chemoimmunotherapy arm vs. the chemotherapy arm. Results exhibit that 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 outcomes. In patients unfit for fludarabine‐containing therapy, with no new safety concerns, addition of ofatumumab to chlorambucil showed clinical advantage and tolerability as a frontline treatment option.

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