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.

Abstract:

: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.

journal_name

Br J Haematol

authors

Offner F,Robak T,Janssens A,Govind Babu K,Kloczko J,Grosicki S,Mayer J,Panagiotidis P,Schuh A,Pettitt A,Montillo M,Werner O,Vincent G,Khanna S,Hillmen P

doi

10.1111/bjh.16625

subject

Has Abstract

pub_date

2020-09-01 00:00:00

pages

736-740

issue

5

eissn

0007-1048

issn

1365-2141

journal_volume

190

pub_type

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