Tumour mutational burden as a driver for treatment choice in resistant tumours (and beyond)
Menée à partir d'échantillons tumoraux fixés au formaldéhyde et inclus en paraffine après prélèvement sur 805 patients atteints d'une tumeur de stade avancé et inclus dans un essai de phase II évaluant le pembrolizumab (durée médiane de suivi : 37,1 mois), cette étude internationale (21 pays) évalue l'association entre la charge mutationnelle de la tumeur et l'efficacité du traitement ainsi que sa toxicité
On June 16, 2020, the US Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab for the treatment of patients with unresectable or metastatic tumour mutational burden-high (TMB-high) solid tumours (as determined by the FDA-approved test, the FoundationOneCDx assay; Foundation Medicine, Cambridge, MA, USA) whose cancer has progressed after previous treatment and who have no satisfactory alternative treatment options. 1
The decision was based on the results of the prespecified analysis of ten cohorts of patients with previously treated unresectable or metastatic TMB-high solid tumours enrolled in the multicentre, non-randomised, open-label, KEYNOTE-158 trial. Aurélien Marabelle and colleagues report the results of this prespecified biomarker analysis in their Article in The Lancet Oncology.
The Lancet Oncology , commentaire, 2019