We are analyzing https://link.springer.com/article/10.1208/s12248-020-00525-1.

Title:
Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker | The AAPS Journal
Description:
Pembrolizumab, an anti–programmed death 1 monoclonal antibody, underwent a rapid clinical development program for the treatment of patients with malignancies in parallel to the development of a companion diagnostic for detecting programmed death ligand 1 (PD-L1) expression, which was considered to be a likely biomarker for response and cancer outcome. When investigating outcomes in patients with non–small cell lung cancer (NSCLC) treated with pembrolizumab, PD-L1 tumor proportion score (TPS) was initially identified as a marker of clinical efficacy, with a cutoff of ≥ 50%. This threshold was later reduced to TPS ≥ 1%, which demonstrated that pembrolizumab offered a clinical benefit in a broader population of patients with PD-L1–expressing tumors. As new evidence emerged, it also became clear that immune cell PD-L1 expression has an important role in predicting tumor response in patients treated with pembrolizumab; the combined positive score (CPS), which accounts for both tumor and immune cell PD-L1 expression, was then applied in clinical studies for indications outside of NSCLC. This review summarizes the outcomes of landmark studies in the KEYNOTE clinical development program that investigated the efficacy of pembrolizumab in patients with a variety of malignancies, the relative outcomes when patients were stratified by PD-L1 status, and how these observations have influenced the approved indications for pembrolizumab.
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Keywords {🔍}

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Topics {✒️}

t-cell-inflamed gene-expression profile phase-3-keynote-361-trial-evaluating-keytruda-pembrolizumab /news/press-release-details/2020/merck small-cell lung cancer small-cell lung cancer month download article/chapter pd-l1–expressing tumors assessing pd-l1 expression gastro-oesophageal junction cancer programmed death ligand-1 real-life clinical samples metastatic-urothelial-carcinoma/default pd-l1 immunohistochemistry assays related subjects blueprint working groups companion diagnostic comparability european medicines agency anti-pd-l1 potential predictive biomarkers pd-1 pathway blockade squamous cell carcinoma pd-l1 expression pd-l1-positive pd-l1–positive pd-l1-expressing privacy choices/manage cookies full article pdf pd-l1 status pd-l1 contributes pd-l1 scoring metastatic urothelial cancer combined positive score gastroesophageal junction cancer pathologist-based assessment advanced urothelial carcinoma european economic area google scholar advanced gastric cancer predictive biomarkers phase 1b trial clin cancer res pérez-gracia jl perez-gracia jl advanced esophageal cancer companion diagnostic piha-paul sa dako north america ethics declarations conflict bristol myers squibb phase ii keynote-059

Questions {❓}

Tumor cells versus host immune cells: whose PD-L1 contributes to PD-1/PD-L1 blockade mediated cancer immunotherapy?

Schema {🗺️}

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