ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) applied to CHECKMATE-141 data for Opdivo (nivolumab) for head and neck cancer- BMS

The results of the first study analysing the application of the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) in a real-life context for rare tumour entities, were announced at the ESMO 2016 Congress in Copenhagen. The ESMO-MCBS is a new tool to quantify the clinical benefit of a certain drug for the treatment of cancer and its application in daily clinical practice. It was first evaluated on common tumour entities by one of Europe’s largest cancer centres, the Medical University of Vienna (MUV), which also conducted this new study.

The ESMO-MCBS has been designed to assess the therapeutic benefit of drugs registered for the treatment of cancer. It considers the predefined primary and secondary study endpoints: overall survival and progression-free survival in terms of absolute gain and lower end of the 95% confidence interval of the corresponding hazard ratio and quality of life or toxicity respectively. Data of the new treatment is then analysed with respect to the duration of response or survival in the control arm, which has to be entered in corresponding forms and results in a clinical benefit ranking. In head and neck cancers, the CHECKMATE-141 data for nivolumab, currently shows an ESMO-MCBS score of 3 (field testing) based on available results but might improve to an even stronger recommendation with more mature survival data.

See- Abstract 1364O_PR “The ESMO-Magnitude of Clinical Benefit Scale (MCBS) in rare tumour entities: A real life experience at the Medical University Vienna” presented by Barbara Kiesewetter during the Proffered Paper session, Public health and health economics-ESMO 2016 Congress .

See- Ferris RL, Blumenschein GR, Fayette J, et al. "Further evaluations of nivolumab (nivo) versus investigator’s choice (IC) chemotherapy for recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): CheckMate 141". 2016 ASCO Annual Meeting J Clin Oncol 34, 2016 (suppl; abstr 6009).