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Poster display session

3489 - Comparability of programmed death-ligand 1 (PD-L1) expression on tumor-infiltrating immune cells (IC) and tumor cells (TC) in advanced urothelial bladder cancer (UBC) using clinically relevant immunohistochemistry (IHC) assays


10 Sep 2017


Poster display session


Kristina Schwamborn


Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376


K. Schwamborn1, R. Knüchel2, A. Hartmann3, G. Baretton4, F. Lasitschka5, P. Schirmacher6, T. Braunschweig2, R. Tauber7, F. Erlmeier8, S. Hieke-Schulz9, J. Ammann10, W. Weichert8

Author affiliations

  • 1 Institut Für Pathologie, Technische Universität München, 81675 - München/DE
  • 2 Instituts Für Pathologie, Uniklinik RWTH Aachen, Aachen/DE
  • 3 Pathologie, Universität Erlangen-Nürnberg, Nürnberg/DE
  • 4 Institut Für Pathologie, Universitätsklinikum Carl-Gustav Carus Dresden, Dresden/DE
  • 5 Pathologisches Institut, Universitätsklinikum Heidelberg, Heidelberg/DE
  • 6 Pathologisches Intitut, Universitätsklinikum Heidelberg, Heidelberg/DE
  • 7 Klinik Und Poliklinik Für Urologie, Technische Universität München, München/DE
  • 8 Institut Für Pathologie, Technische Universität München, München/DE
  • 9 Biostatistics, Roche Pharma AG, Grenzach-Wyhlen/DE
  • 10 Medical Affairs, Roche Pharma AG, Grenzach-Wyhlen/DE


Abstract 3489


PD-L1/PD-1 checkpoint inhibitors have shown clinical activity in UBC. It has been shown that PD-L1 expression on TC and/or IC correlates with clinical efficacy. In this study (ML39708) we examined technical comparability and inter-reader agreement of 4 clinically relevant assays for PD-L1 expression on IC and TC in locally advanced UBC.


Archived formalin-fixed paraffin-embedded sections from 30 patients with locally advanced UBC (70% cystectomies, 30% transurothelial resections) were selected from 150 cases based on PD-L1 status per VENTANA SP142 IC  5% (10 cases each). The study cohort was stained for PD-L1 using SP142, SP263 (VENTANA), 22C3, and 28-8 (DAKO) assays at two sites according to manufacturer protocols. Stainings were blinded and scored at 5 sites for the PD-L1 expression on IC (% per tumor area) and TC (%). All readers were trained on scoring IC with SP142.


Percentage of IC cells staining for PD-L1 varied from 6.54 to 8.18%, and TC from 5.46 to 15.85%, depending on the assay used (Table). For each assay, IC staining varied slightly to moderately between readers, with small non-significant differences between assays. Results for TC were comparable except for significantly lower staining with SP142. Pairwise comparison revealed –0.3 to 1.6% differences in adjusted means between assays for IC, and for TC, –10.5 to –7.8% (SP142 vs other assays) and –1.9 to 2.7% (other comparisons). Retrospective allocation to binary cut-offs (1%, 5% and 10%) for IC or TC only predominantly showed substantial or high Kappa agreement scores (0.6–0.8) for IC and TC between assays for each reader.Table:


AssayPD-L1 on IC %Reader ICCPD-L1 on TC %Reader ICC
(95% CI)*(95% CI)*
VENTANA SP1428.18 (7.32–9.03)0.6995.46 (2.85–8.07)0.609
VENTANA SP2637.08 (6.22–7.94)0.72915.85 (13.24–18.47)0.805
DAKO 22C36.54 (5.68–7.39)0.53213.19 (10.57–15.80)0.883
DAKO 28-86.88 (6.02–7.74)0.57315.15 (12.54–17.77)0.845

Adjusted means for each assay;

Intra-class correlation per test between 5 readers


This is the first multicenter study for analytical comparison of PD-L1 IHC staining on IC and TC in UBC. High concordance rates across all assays were achieved between trained readers for scoring PD-L1 on IC and TC.

Clinical trial identification


Legal entity responsible for the study

Roche Pharma AG


Roche Pharma AG


A. Hartmann: Membership of an advisory board: Roche, MSD, AstraZeneca Corporate-sponsored research: Novartis, Biontech, Illumina, Nanostring, Quiagen. G. Baretton: Membership of an advisory board Roche, Bristol-Myers Squibb, AstraZeneca Corporate-sponsored research Roche, Bristol-Myers Squibb. F. Lasitschka: Membership of an advisory board: Roche NSCLC regional advisory board. Bristol-Myers Squibb NSCLC regional advisory board Corporate-sponsored research: Roche PLACU study. P. Schirmacher: Roche (Research, Honorarium) Bristol-Myers Squibb (Research, Honorarium), MSD (Research, Honorarium), AstraZeneca (Research, Honorarium), Novartis (Research, Honorarium). T. Braunschweig: Membership of an advisory board and invited guest speaker: Bristol-Myers Squibb Invited guest speaker: MSD Corporate-sponsored research: Roche. R. Tauber: Membership of an advisory board: Roche, Sanofi, Bristol-Myers Squibb) Corporate-sponsored Research: conduct as subinvestigator of clinical trials. S. Hieke-Schulz: Employee Roche Pharma AG. J. Ammann: Stock ownership: Roche Pharmaceuticals Other substantive relationships: Employee of Roche Pharma AG. W. Weichert: Conflicts of interest Advisory boards for Roche, AstraZeneca, MSD, Bristol-Myers Squibb, Pfizer, Novartis, Boehringer. Collaborative research with Roche, Novartis, AstraZeneca, Boehringer. All other authors have declared no conflicts of interest.

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