Analysis of PD-L1 expression was performed on formalin-fixed paraffin-embedded tumor tissue sections from metastatic lesions or primary tumors (if sufficient metastatic tissue was unavailable). The tumor sections were stained with an anti–PD-L1 antibody (1:100; E1L3N rabbit monoclonal antibody; Cell Signaling Technology, Danvers, MA) according to a standard protocol.8 (link),9 (link) The percentage of PD-L1–positive tumor cells was independently scored by three pathologists who were blinded to clinical outcomes. Discrepancies in scores were resolved by consensus review. For patients with PD-L1 measures from both metastatic and primary lesions, preference was given to the metastatic lesion score. For statistical analysis, PD-L1 scores were categorized as 0%, 1%-5%, > 5%-20%, or > 20% to study for association with clinical outcomes. The baseline PD-L1 score was used for analysis of efficacy in part B.
Protocol detail
Assessing PD-L1 Expression in Tumor Tissues
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Anti antibody
Embedded paraffin
Formalin
Monoclonal antibody
Pathologists
Patients
Pd l1
Rabbit
Tissue
Tumor
Corresponding Organization :
Other organizations : Dana-Farber Cancer Institute, University of Pennsylvania, Beth Israel Deaconess Medical Center, Emory University, Weinberg Medical Physics (United States), Columbia University, Northwestern University, Hackensack University Medical Center, Fox Chase Cancer Center, Cleveland Clinic, Yale Cancer Center, Yale University, University of Illinois Chicago, Brigham and Women's Hospital, The University of Texas Southwestern Medical Center
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Variable analysis
independent variables
- PD-L1 expression
- Percentage of PD-L1–positive tumor cells
- Formalin-fixed paraffin-embedded tumor tissue sections from metastatic lesions or primary tumors
- Staining with an anti–PD-L1 antibody (1:100; E1L3N rabbit monoclonal antibody; Cell Signaling Technology, Danvers, MA) according to a standard protocol
- Three pathologists who were blinded to clinical outcomes to independently score the percentage of PD-L1–positive tumor cells
- Consensus review to resolve discrepancies in scores
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