Journal article

The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

Paula Gonzalez-Ericsson, Elisabeth S Stovgaard, Luz F Sua, Emily Reisenbichler, Zuzana Kos, Jodi M Carter, Stefan Michiels, John Le Quesne, Torsten O Nielsen, Anne-Vibeke Laenkholm, Stephen B Fox, Julien Adam, John MS Bartlett, David L Rimm, Cecily Quinn, Dieter Peeters, Maria Dieci, Anne Vincent-Salomon, Ian Cree, Akira Hida Show all



Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be eas..

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