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

Fritz Offner; Tadeusz Robak; Ann Janssens; K Govind Babu; Janusz Kloczko; Sebastian Grosicki; Jiri Mayer; Panagiotis Panagiotidis; Anna Schuh; Andrew Pettitt; Marco Montillo; Olena Werner; Ghislaine Vincent; Sadhvi Khanna; Peter Hillmen

doi:10.1111/bjh.16625

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

Br J Haematol. 2020 Sep;190(5):736-740. doi: 10.1111/bjh.16625. Epub 2020 Mar 31.

Authors

Affiliations

¹ Department of Hematology, University Hospital Ghent, Gent, Belgium.
² Department of Haematology, Medical University of Lodz, Lodz, Poland.
³ Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
⁴ Department of Medical Oncology, Kidwai Memorial Institute of Oncology, HCG Hospitals, Bangalore, India.
⁵ Department of Hematology, Medical University of Bialystok, Bialystok, Poland.
⁶ Medical University of Silesia, Katowice, Poland.
⁷ Department of Internal Medicine, Haematology and Oncology, Masaryk University Hospital Brno, Brno, Czech Republic.
⁸ Haematology Department, Department of Internal Medicine University of Athens, Laikon General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.
⁹ Department of Oncology, University of Oxford, Oxford, UK.
¹⁰ University of Liverpool, Liverpool, UK.
¹¹ Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.
¹² Novartis Pharma AG, Basel, Switzerland.
¹³ Novartis Pharma S.A.S, Paris, France.
¹⁴ Department of Haematology, St James's University Hospital, Leeds, UK.

PMID: 32236950
DOI: 10.1111/bjh.16625

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.

Keywords: Complement 1; anti-CD20 monoclonal antibodies; chlorambucil; chronic lymphocytic leukaemia; ofatumumab.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Antibodies, Monoclonal, Humanized / administration & dosage
Antibodies, Monoclonal, Humanized / adverse effects
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Chlorambucil / administration & dosage
Chlorambucil / adverse effects
Disease-Free Survival
Female
Follow-Up Studies
Humans
Leukemia, Lymphocytic, Chronic, B-Cell* / drug therapy
Leukemia, Lymphocytic, Chronic, B-Cell* / mortality
Male
Middle Aged
Survival Rate

Substances

Antibodies, Monoclonal, Humanized
Chlorambucil
ofatumumab

Grants and funding

Novartis Pharma AG