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PD-L1 assessment in urothelial carcinoma: a practical approach
Markus Eckstein1, Alessia Cimadamore2, Arndt Hartmann1
1Institute of Pathology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, 91052, Germany.
Abstract:
Five programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors are currently approved for treatment of locally advanced or metastatic urothelial carcinoma of the bladder and the upper urinary tract. Due to restrictions by the FDA and EMA first-line treatment with Atezolizumab and Pembrolizumab in platinum-ineligible patients requires immunohistochemical PD-L1 testing. In the second-line setting all drugs are approved without PD-L1 testing. Used PD-L1 assays in clinical trials include the 28-8 pharmDx (Nivolumab), the 22C3 pharmDx (Pembrolizumab), Ventana SP142 (Atezolizumab), and the Ventana PD-L1 SP263 assays (Durvalumab). Differences in antibodies, needed platforms and testing algorithms have raised questions about interchangeability and comparability among these assays and their diagnostic use. We provide a practical review about the current recommendations, used assays and algorithms of PD-L1 testing in urothelial carcinoma to help oncologists, urologists and pathologists to understand analytical features, differences in antibody assays, differences in scoring algorithms and comparability of various PD-L1 assays. We reviewed and summarized published studies from the last four years (2016-2019) on PD-L1 testing in bladder cancer and present a condensed practical guideline including pre-analytical, analytical and test-specific issues.
Insights
Five programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors treat urothelial carcinoma. This review clarifies PD-L1 testing assays and algorithms for accurate clinical use in bladder cancer treatment.
Area of Science:
- Oncology
- Immunotherapy
- Diagnostic Pathology
Background:
- Five PD-1/PD-L1 inhibitors are approved for advanced urothelial carcinoma.
- First-line treatment with Atezolizumab and Pembrolizumab requires PD-L1 testing in platinum-ineligible patients.
- Second-line treatment is approved without PD-L1 testing, but various assays are used.
Purpose of the Study:
- To provide a practical review of PD-L1 testing in urothelial carcinoma.
- To help clinicians understand assay differences, algorithms, and comparability.
- To present a condensed guideline on PD-L1 testing issues.
Main Methods:
- Review and summarization of published studies (2016-2019) on PD-L1 testing in bladder cancer.
- Analysis of different PD-L1 assays (28-8, 22C3, SP142, SP263) and their platforms.
- Evaluation of scoring algorithms and analytical features.
Main Results:
- Differences in antibodies, platforms, and algorithms raise questions about assay interchangeability.
- Specific assays are linked to specific PD-1/PD-L1 inhibitors (e.g., 28-8 for Nivolumab, 22C3 for Pembrolizumab).
- Variations exist in testing requirements between first-line and second-line settings.
Conclusions:
- Understanding the analytical features and differences of PD-L1 assays is crucial for accurate diagnosis and treatment selection.
- Standardization or clear guidelines on assay comparability are needed for optimal clinical application.
- This review offers practical insights for oncologists, urologists, and pathologists managing urothelial carcinoma.
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