A Multi-Institutional Study to Evaluate Automated Whole Slide Scoring of Immunohistochemistry for Assessment of Programmed Death-Ligand 1 (PD-U) Expression in Non-Small Cell Lung Cancer

摘要

Pembrolizumab, a humanized antibody targeting programmed death receptor 1, was recently approved by the Food and Drug Administration (FDA) for first-line ther-% apy of patients with advanced non-small cell lung carcinoma.1 The programmed death-ligand 1 (PD-L1) immunohistochemistry 22C3 pharmDx Kit (Agilent-Dako) is an approved companion diagnostic that detects the corresponding ligand, PD-L1. The companion diagnostic test is an on-label requirement for prescription of pembrolizumab in the first-line setting and uses a clinical scoring approach to classify patients for treatment on the basis of tumoral PD-L1 expression, m lung cancers, PD-L1 expression is evaluated by the Tumor Proportion Score (TPS). The specimen is considered to have PD-L1 expression if the TPS is > 1% and has high PD-L1 expression if the TPS is >50%; in clinical trials pembrolizumab showed a high response rate in patients with over 50% ligand expression.2'-* The test is optimized to a threshold value based upon the number of cells showing PD-L1 expression on tumor cell (TC) membranes4 at or above the threshold intensity. In lung cancer, the 22c3 pharmdx test does not evaluate non-TCs but now does for its use in gastric or cervical cancer. The stromal cells, also called "immune cells," are defined based on the complementary diagnostic test for atezolizumab but are now evaluated in diagnostic tests associated with other programmed death 1 axis drugs.