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Eckstein, M et al. Eur J Cancer 2019

approved PD-L1 assays in

urothelial carcinoma

28-8 and the SP263 assays (

Fig. 1

E;

Table S4

).

Compared with the SP142 assay, pooled OPA across

prespecified algorithm cut-offs was 82.0% (range:

3.8. Agreement across different clinical important cut-offs

for first-line therapy selection with atezolizumab and

pembrolizumab

Table 1

Positive percentage agreement (PPA) and negative percentage agreement (NPA) in 251 muscle-invasive bladder cancer specimens across different

PD-L1 assay algorithms.

Reference assay

Comparator assay at matched expression cut-off

Dako 28-8

Dako 22c3

Ventana SP142

Ventana SP263

PPA

NPA

PPA

NPA

PPA

NPA

PPA

NPA

DAKO 28

-

8

<

/

!

5% TC

88.1% 96.4% 44.0% 99.4% 85.0% 95.2%

DAKO 22c3

<

/

!

10 CPS

95.5% 92.6%

46.6% 100% 92.0% 89.6%

Ventana SP142

<

/

!

5% IC

73.2% 86.7% 78.0% 90.0%

82.9% 81.0%

Ventana SP263

<

/

!

25% TC- or IC

90.0% 98.8% 85.7% 99.4% 30.0% 100%

TC, tumour cells; IC, immune cells; CPS, combined positive score.

PPA

!

85% indicates interchangeability of diagnostic assays.

M. Eckstein et al. / European Journal of Cancer 106 (2019) 234

e

243

238