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e-Poster Display Session

13P - PD-L1 prevalence in advanced urothelial carcinoma by demographic and clinical characteristics


09 Dec 2020


e-Poster Display Session


Thomas Powles


Annals of Oncology (2020) 31 (suppl_7): S1417-S1424. 10.1016/annonc/annonc389


T. Powles1, M. van der Heijden2, A. Balar3, P. O'Donnell4, C. Massard5

Author affiliations

  • 1 Bart's Cancer Institute, London/GB
  • 2 Netherlands Cancer Institute, Amsterdam/NL
  • 3 Perlmutter Cancer Center, NYU Langone Medical Center, New York/US
  • 4 University of Chicago Medical Center, Chicago/US
  • 5 Gustave Roussy - Cancer Campus, Villejuif/FR

Abstract 13P


High PD-L1 expression in tumor cells (TCs) and/or immune cells (ICs) has been linked to the efficacy of PD-1/PD-L1 inhibitors in urothelial carcinoma (UC). However, PD-L1 expression in tumor-infiltrating ICs has also been linked to improved prognosis in UC, which may confound analysis of its value as a predictive biomarker for immunotherapy. To better understand the prognostic role of PD-L1 in UC, we investigated the association of PD-L1 expression with clinical and demographic characteristics.


PD-L1 expression in tumor biopsy samples from studies CD-ON-MEDI4736-1108 (NCT01693562) and D4910C00010 (NCT02261220) was assessed using the VENTANA PD-L1 (SP263) Assay. The specimens were scored at TC≥25%, IC ≥25%, TC or IC≥25%. The clinically relevant cutoff of IC≥5% (as percentage of tumor area) was also derived. Prevalence was reported for various clinical and demographic groups and significance calculated using Fisher’s exact test, adjusted for multiple testing with Benjamini-Hochberg method.


PD-L1 expression as defined by IC≥5% (as percentage of tumor area) was associated with the highest number of positive prognostic factors, including ECOG performance status, Bellmunt scores, absence of visceral metastases at baseline, and lower tumor burden (Table). TC/IC25% was associated only with absence of visceral metastases at baseline (adjusted p value 0.003). IC≥25% was independently associated with the absence of visceral metastases and favorable Bellmunt score, but TC≥25% alone was not.


Higher PD-L1 expression in ICs is associated with clinically favorable characteristics in UC. IC-driven PD-L1 algorithms such as IC≥5% (by tumor area) are more strongly associated with known favorable prognostic indicators than those incorporating TCs. These findings may have implications for clinical studies where PD-L1 expression is utilized as a selective biomarker. Table: 13P

Characteristic Category n % PD-L1 high (TC/IC≥25%) Adjusted P-value % PD-L1 high (IC≥5%) Adjusted P-value
Smoking status Current 36 56 0.90 8.3 0.76
Former 182 51 14.3
Never 120 47 10.0
Baseline liver metastases N 221 53 0.32 14.9 0.15
Y 117 44 6.8
Baseline visceral metastases N 94 67 0.003 24.5 0.001
Y 244 43 7.4
Baseline lymph only invovlement N 287 46 0.05 9.1 0.002
Y 51 69 29.4
Ecog ps 0 114 54 0.50 21.9 0.002
1 224 48 7.1
2 1 0 0.0
Bellmunt score 0 74 53 0.32 23.0 0.03
1 136 54 12.5
2 105 40 5.7
3 23 61 4.3
Tumor burden 163 52 0.90 17.2 0.04
≥median 175 48 7.4
Sample method collection Biopsy 234 46 0.32 12.8 0.87
Excision/Resection 61 57 9.8
Other 1 100 0.0
Sample location Metastatic 263 48 0.32 12.9 0.76
Primary 76 58 9.2

Clinical trial identification

NCT01693562, NCT02261220.

Editorial acknowledgement

Medical writing and editorial support provided by Ward A. Pedersen, PhD, of Parexel, funded by AstraZeneca.

Legal entity responsible for the study





T.B. Powles: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self), Research grant/Funding (institution): Exelixis; Honoraria (self): Incyte; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck/MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Research grant/Funding (institution): Seattle Genetics; Honoraria (self), Research grant/Funding (institution): Merck Serono; Honoraria (self), Research grant/Funding (institution): Astellas; Honoraria (self), Research grant/Funding (institution): Johnson & Johnson; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche. M.S. van der Heijden: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca/MedImmune; Advisory/Consultancy, Research grant/Funding (self): Bristol Myers Squibb; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Research grant/Funding (self): Roche/Genentech; Advisory/Consultancy: Seattle Genetics. A.V. Balar: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca/MedImmune; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy: Cerulean Pharma; Advisory/Consultancy: Incyte; Advisory/Consultancy: Pfizer/EMD Serono; Advisory/Consultancy: Seattle Genetics/Astellas; Research grant/Funding (institution): Seattle Genetics. P. O'Donnell: Shareholder/Stockholder/Stock options: Allergan; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech/Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Honoraria (self): Astellas Pharma; Honoraria (self), Research grant/Funding (institution): Seattle Genetics; Honoraria (self): OncLive; Honoraria (self): Atheneum Partners; Honoraria (self): Health Advances; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Honoraria (self): Dedham Group; Honoraria (self): Schlesinger Associates; Honoraria (self): FirstWord Publication; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): AstraZeneca/MedImmune; Research grant/Funding (institution): Acerta Pharma; Research grant/Funding (institution): Bristol Myers Squibb. C. Massard: Advisory/Consultancy: Amgen; Advisory/Consultancy: Astellas Korea; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: BeiGene; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Celgene; Advisory/Consultancy: Debiopharm Group; Advisory/Consultancy: Genentech. J. Walker: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. A. Gupta: Advisory/Consultancy, Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. N. Angra: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: MedImmune/AstraZeneca. J. Cairns: Full/Part-time employment: AstraZeneca. B. Turriziani: Full/Part-time employment: AstraZeneca. M.C. Rebelatto: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. M. Scott: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. S. Wildsmith: Full/Part-time employment: AstraZeneca.

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