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Immune-checkpoint inhibitors (ICIs) have substantially improved the outcomes of large subsets of patients across numerous malignancies. However, the lack of durable responses in many patients, added to high costs and the risk of adverse events, indicates a need for better biomarkers to guide patient selection. PD-L1 expression as measured routinely by immunohistochemistry (IHC), providing clinicians with a combined positivity score (CPS), microsatellite instability (MSI), and tumor mutational burden (TMB) have emerged as the most widely used and relevant biomarkers of response to ICIs. These biomarkers have variably succeeded or failed in predicting responders for different cancer types in adequately powered trials. Further, their prognostic and/or predictive roles are limited to specific settings.
Grossman et al. (Tue,) studied this question.