Five-year survival follow-up of a phase III randomised trial comparing ofatumumab versus physicians' choice for bulky fludarabine-refractory chronic lymphocytic leukaemia: a short report.

Udvardy Miklos, Vladimir Strugov, Catharina Lewerin, Sebastian Grosicki, Grzegorz Mazur, Michael Steurer, Marco Montillo, Irina Kryachok, Jan M Middeke, Grygoriy Rekhtman, Tommaso Stefanelli, Ghislaine Vincent, Sameera Govindaraju, Anders Österborg

Journal: British journal of haematology 2021;189(4):689-693

PMID: 31994178

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Abstract

In 2014, an interim analysis of a phase 3 study was performed to evaluate the effectiveness of ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL) as compared to physician's choice. The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival. As only few patients had the chance to receive a kinase inhibitor later, the study displays the survival of BFR CLL patients in the period prior to receiving small-molecule inhibitors. Ofatumumab is a well-tolerable treatment option in multiresistant advanced CLL.

Address: Department of Hematology, Debrecen University, Debrecen, Hungary.; Almazov National Medical Research Centre, St. Petersburg, Russian Federation.; Section of Hematology and Coagulation, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Department of Hematology and Cancer Prevention, Medical University of Silesia, Katowice, Poland.; Wroclaw Medical University, Wroclaw, Poland.; Innsbruck Medical University, Innsbruck, Austria.; Department of Onco-Hematology, Division of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.; Oncohematology, National Cancer Institute, Kyiv, Ukraine.; Medizinische Klinik I, Universitaetsklinikum C.G.Carus, Dresden, Germany.; Khmelnytskyi Regional Hospital, Khmelnytskyi, Ukraine.; Novartis Pharma AG, Basel, Switzerland.; Novartis Pharma S.A.S, Paris, France.; Novartis Healthcare Pvt. Ltd., Hyderabad, India.; Department of Hematology, Karolinska University Hospital, Stockholm, Sweden.

DOI: 10.1111/bjh.16429

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MeSH Terms: Antibodies, Monoclonal, Humanized, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Survival Analysis, Vidarabine