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Poster Display session 3

5877 - Efficacy of anti-PD(L)1 treatment in patients with metastatic urothelial cancer based on mRNA- and protein- based PD-L1 determination: Results from the multicentric, retrospective FOsMIC trial


30 Sep 2019


Poster Display session 3


Tumour Site

Urothelial Cancer


Jonas Jarczyk


Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249


J. Jarczyk1, R. Wirtz2, F. Roghmann3, H. Juette4, M.C. Kriegmair5, T.S. Worst5, D. Sikic6, S. Wach7, H. Taubert7, B. Wullich7, V. Weyerer8, R. Stoehr8, F. Zengerling9, C. Bolenz10, J. Breyer11, M. Burger11, S. Porubsky12, A. Hartmann13, P. Erben14, M. Eckstein8

Author affiliations

  • 1 Department Of Urology Mannheim, Medical Faculty Mannheim, University of Heidelberg, 68167 - Mannheim/DE
  • 2 On Behalf Of The Bridge-consortium E.v., STRATIFYER Molecular Pathology GmbH, Cologne, 50935 - Cologne/DE
  • 3 Urologic Department Of The Ruhr - University Bochum, Marienhospital Herne, 44625 - Herne/DE
  • 4 Department Of Pathology, Ruhr University Bochum, Bochum/DE
  • 5 Urology, University Hospital Mannheim, Ruprecht-Karls-University Heidelberg, Mannheim, 68159 - Mannheim/DE
  • 6 Department Of Urology And Pediatric Urology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen/DE
  • 7 Department Of Urology And Pediatric Urology, Universitätsklinik Erlangen, 91054 - Erlangen/DE
  • 8 Institute Of Pathology, Universitätsklinik Erlangen, 91054 - Erlangen/DE
  • 9 Department Of Urology, University Hospital Ulm, University of Ulm, Ulm, 89081 - Ulm/DE
  • 10 Department Of Urology, University of Ulm, Ulm/DE
  • 11 Department Of Urology, University of Regensburg, Regensburg/DE
  • 12 Institute Of Pathology, Medical Faculty Mannheim, University of Heidelberg, Mannheim/DE
  • 13 Institute Of Pathology, Universitätsklinik Erlangen, 91052 - Erlangen/DE
  • 14 Department Of Urology Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim/DE


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Abstract 5877


Immunotherapy (IO) with antibodies against PD1 or PD-L1 has been approved for 1st and 2nd line treatment of metastasized urothelial bladder cancer (mUC). Here we evaluated efficacy in a retrospective Real-World-Phase IV trial based on molecular subtypes and PD-L1 status.


Cancer specific survival from start of IO treatment to death was retrospectively analyzed in a multicenter cohort of 65 patients having received palliative immune checkpoint inhibition for mUC in 1st and 2nd line setting. Intrinsic molecular subtypes were assessed by CK5, CK20, GATA3, FOXA1 and CD44 immunohistochemistry and RT-qPCR of KRT5 and KRT20. PD-L1 status was determined using the 28-8 Dako-assay. Stromal tumor infiltrating lymphocytes were assessed on HE slides (Salgado et al, 2015). Survival analyses were performed by applying clinically relevant cut-offs and using Kaplan-Meier analysis and logistic regression for cancer specific survival (CSS).


Altogether, 43% of tumors presented with basal differentiation, 57% were luminal. As expected, basal tumors exhibited significantly higher levels of PD-1 and PD-L1 gene expression, higher amounts of sTILs and PD-L1+ immune and tumor cells. Hierarchical clustering of all immunological biomarkers revealed three cluster: “Inflamed high” (n = 13, 20%), “Inflamed low” (n = 22, 33.8%), and “Uninflamed” (n = 30, 46.2%). There were no significant survival differences for any of these groups (CSS). However, patients with good performance status (ECOG 0) and low PD-L1 expression showed significantly better CSS compared to those with ECOG0 / PD-L1 high and ECOG1 or ECOG2, respectively (30.3 months vs. 16.33, 12.07 and 15.13 months; p = 0.0047).


Immunological determinants of mUC show comparable distributions and correlations with subtypes of localized curatively treated MIBC patients. Interestingly, data indicate improved CSS after PD-1/PD-L1 treatment in patients with good performance and low PD-L1 expression, which warrants validation in larger cohorts.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

STRATIFYER Molecular Pathology GmbH.


Janssen-Cilag GmbH.


R. Wirtz: Leadership role: CEO & CSO, STRATIFYER Molecular Pathology GmbH. All other authors have declared no conflicts of interest.

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