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MSL Talk: Tom Caravela, Charlie Cook
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
Summary
- The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts.
- A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myeloma, and myelodysplastic syndromes.
- The objectives were to evaluate data scorability, assess the reasonableness of clinical benefit grades, and identify any shortcomings needing amendments.
- The ESMO-MCBS v1.1 was generally applicable, with scores deemed reasonable by European Hematology Association experts, although some studies could not be graded appropriately due to differences from solid tumour malignancies.
- ESMO and EHA are committed to developing a validated version for haematological malignancies, incorporating stringent processes for accountability.
- The application of such a validated scale will aid public policy decision-making and inform the design of future clinical trials.
In recent years, rapid developments in haematology research resulted in a considerable expansion of treatment options. The development of instruments to measure clinical benefit is essential in the current scenario where increasing numbers of treatments for haematological malignancies (HMs) are becoming available, often targeting a small and defined subpopulation of patients. For this, several value frameworks have been published by different organisations and institutions taking into account or emphasising different aspects contributing to such an evaluation. These frameworks vary in terms of their definition of value, target audience and methodology, and each of them has specific limitations, which should be taken into consideration when interpreting their outputs. Until now, value frameworks developed in oncology have not been validated in the setting of HMs.
The European Society for Medical Oncology (ESMO) has developed such a value framework called the ESMO—Magnitude of Clinical Benefit Scale (ESMO-MCBS). Initially published in 2015, the scale is a validated and reproducible tool in solid tumour oncology with a particular focus on the clinical benefit. The ESMO-MCBS was developed to generate clear, valid and unbiased grading of the magnitude of clinical benefit demonstrated in therapeutic studies that could be used for a number of purposes incl
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ESMO, hematological malignancies, Clinical benefit scale, EHA
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