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In people with myelodysplastic neoplasms (MDS), a usually benign form of chronic lymphocytic leukaemia, the body produces too few functional blood cells. Affected individuals suffer from anaemia – a lack of red blood cells or haemoglobin – which can be a precursor to acute leukaemia. Compared to the standard treatment, luspatercept can increase haemoglobin levels in MDS patients and help them to avoid blood transfusions. These are the findings of an international clinical trial led by Professor Uwe Platzbecker from Leipzig University and the University of Leipzig Medical Center in collaboration with a large international research team.
Every year, around 4000 people in Germany alone are diagnosed with myelodysplastic neoplasms (MDS). In these patients, the healthy maturation of blood cells is disrupted, which can lead to anaemia, infections and an increased risk of bleeding. High-risk MDS is characterised by rapid progression, severe symptoms and often a transition to acute leukaemia that results in a short life expectancy.
Patients who fall into the low-risk category of MDS are not initially in an acutely life-threatening situation, but often suffer from mild to moderate anaemia as a result of a lack of mature and functional red blood cells. This type of anaemia manifests itself primarily through reduced performance as well as extreme fatigue and tiredness, which severely limit the quality of life of those affected. And anaemia can often only be adequately treated with regular blood transfusions. A certain proportion of patients benefit from treatment with epoetin alfa – currently the only standard of care – before or in addition to blood transfusions. However, as a result of certain biological parameters, epoetin alfa is not suitable for all patients and the effect is usually not permanent.
In a recent international study, luspatercept showed significantly better results compared to epoetin alfa in the initial treatment of low-risk MDS patients. Professor Uwe Platzbecker, director of the Department for Hematology, Cell Therapy, Hemostaseology and Infectious Diseases at Leipzig University Hospital played a leading role in developing the clinical research project and recently presented this milestone at the European Hematology Congress in Frankfurt. “The results of this initial analysis of the COMMANDS trial will influence the treatment algorithm for low-risk MDS patients requiring transfusions and likely establish luspatercept as a first-line treatment option in this group,” says Professor Platzbecker, first author of the current publication. The results were published in the prestigious medical journal “The Lancet”.
The results are based on an interim analysis. Data were analysed from 147 study participants who received luspatercept and 154 study participants who were assigned to the epoetin alfa group. The objective of the study was to avoid blood transfusions over a period of twelve weeks and to increase haemoglobin levels by at least 1.5 points. A significantly higher number of patients treated with luspatercept (59 per cent in total) met the primary endpoint. In comparison, the objective was achieved by only 31 per cent of those in the epoetin alfa group.
The COMMANDS trial is designed as an open-label, randomised phase 3 trial and is being conducted at a total of 142 centres in 26 countries. Eligible patients required red blood cell transfusions at the time of study entry and had not previously received the standard treatment. Professor Platzbecker has been involved in clinical research on myelodysplastic neoplasms for more than 20 years. The COMMANDS trial follows a comprehensive study programme on the active ingredient luspatercept, which Professor Platzbecker has been involved in both medically and scientifically, in partnership with the manufacturer. The current clinical trial was sponsored by Celgene and Acceleron Pharma.
Translation: Kerstin Gackle
Professor Uwe Platzbecker
Director of the Department for Hematology, Cell Therapy, Hemostaseology and Infectious Diseases
Professor of Haematology, Leipzig University
Tel: +49 341 97 13 050
Email: Uwe.Platzbecker@medizin.uni-leipzig.de
Original publication in The Lancet:
Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. https://doi.org/10.1016/S0140-6736(23)00874-7
The study objective was to avoid blood transfusions over a period of twelve weeks.
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Professor Uwe Platzbecker
Stefan Straube
University of Leipzig Medical Center
Correction: In the first English version of the press release, there was an error in the translation of the name of the disease in question in the headline and teaser. The correct name and translation is “anaemia in myelodysplastic neoplasms (MDS)”. Please also use this terminology in the teaser of the text, instead of “anaemia in chronic lymphocytic leukaemia”.
The full corrected version of the English press release is also available on the English website of Leipzig University: https://www.uni-leipzig.de/en/newsdetail/artikel/milestone-in-the-treatment-of-a...
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The study objective was to avoid blood transfusions over a period of twelve weeks.
Colourbox
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Professor Uwe Platzbecker
Stefan Straube
University of Leipzig Medical Center
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