VENTANA PD-L1 (SP142) AssayIdentify triple-negative breast cancer (TNBC) patients eligible for TECENTRIQ®

PredictiveUS FDA Approved

Your assay choice matters

Using the right test to determine PD-L1 status for immunotherapy options is important. The VENTANA PD-L1 (SP142) Assay gives you the confidence to reliably identify triple-negative breast cancer (TNBC) patients eligible for TECENTRIQ® (atezolizumab).1, 2

The novel VENTANA PD-L1 (SP142) Assay is easy to score and the first with FDA approval to evaluate breast cancer patients for PD-L1 expression using immune cell staining and scoring within the tumor microenvironment. The assay provides you with information that multidisciplinary teams need to guide immunotherapy decisions in TNBC.

Staining characteristics in triple-negative breast cancer (TNBC)General guidance

A patient’s TNBC tissue stained with the VENTANA PD-L1 (SP142) Assay is evaluated for tumor-infiltrating immune cell (IC) staining. IC are immune cells present in the intratumoral and contiguous peritumoral stroma that include lymphocytes, macrophages, dendritic cells and granulocytes. IC are scored as the proportion of tumor area that is occupied by PD-L1 staining IC of any intensity.

Figure 1: TNBC tissue stained with the VENTANA PD-L1 (SP142) Assay. All images scanned at 10x. Immune cells often show dark brown punctate or linear staining, which is the predominant IC staining pattern observed in the majority of tissues. Occasionally, circumferential IC membrane staining is also observed, especially in cells that are morphologically consistent with macrophages and/or dendritic cells. (a) TNBC tissue with PD-L1 expression <1% in IC by the VENTANA PD-L1 (SP142) Assay; (b), (c), (d), (e), (f) TNBC tissue with PD-L1 expression ≥1% in IC by the VENTANA PD-L1 (SP142) Assay.

a

d

b

e

c

f

PD-L1 expression clinical relevance in metastatic TNBCA statistically and clinically meaningful progression-free survival (PFS) benefit was observed when adding TECENTRIQ to nab-paclitaxel in PD-L1+ population.4

(g) Kaplan–Meier Analysis of PFS among patients whose tumors showed PD-L1 expression ≥1%1 IC, according to scoring algorithm in TNBC.4

VENTANA PD-L1 (SP142) Assay scoring algorithm* for TNBC

* For detailed information on scoring algorithm please refer to VENTANA PD-L1 (SP142) Assay Package Insert and Interpretation Guide for TNBC 2, 3

Staining criteria/characteristics PD-L1 expression

Absence of any discernible PD-L1 staining [OR] presence of discernible PD-L1 staining of any intensity in tumor-infiltrating immune cells covering <1% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peritumoral stroma.

<1% IC

Presence of discernible PD-L1 staining of any intensity in tumor-infiltrating immune cells covering ≥1% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peritumoral stroma.

≥1% IC

Report PD-L1 expression on tumor-infiltrating immune cells (IC) as

100

80

60

40

20

0

0 3 6 9 12 15 18 21 24 27 30 33

Prog

ress

ion-

free

sur

viva

l (%

)

Months

g

<1% IC or ≥1% IC

Stratified HR=0.62(95% CI: 0.49, 0.78)

p<0.0001

7.5 mo(6.7, 9.2)

5.0 mo(3.8, 5.6)

References

1. gene.com. (2019). TECENTRIQ Prescribing Information. [online] Available at: https://www.gene.com/download/pdf/tecentriq_prescribing.pdf [Accessed 11 Mar. 2019].

2. productlibrary.ventana.com. (2019). Ventana Product Document Library. U.S. VERSION - Package Insert, VENTANA PD-L1 (SP142) Assay. [online] Available at: http://productlibrary.ventana.com/ventana_portal/OpenOverlayServlet?launchIndex=1&objectId=740-48591017981US [Accessed 11 Mar. 2019].

3. productlibrary.ventana.com. (2019). Ventana Product Document Library. U.S. VERSION - Interpretation Guide for Triple-Negative Breast Carcinoma, VENTANA PD-L1 (SP142) Assay. [online] Available at: http://productlibrary.ventana.com/ventana_portal/OpenOverlayServlet?launchIndex=1&objectId=740-48591018231EN [Accessed 12 Mar. 2019].

4. P Schmid, et al. N Engl J Med 2018. DOI: 10.1056/NEJMoa1809615.

Ordering information

Product name Catalog number Ordering code Tests

VENTANA PD-L1 (SP142) Assay Positive Control: Tonsil Species: Rabbit Localization: Membranous and/or Cytoplasmic

740-4859 07709374001 50

OptiView DAB IHC Detection Kit 760-700 06396500001 250

OptiView Amplification Kit 860-099 06718663001 250

Rabbit Monoclonal Negative Control Ig 790-4795 06683380001 50

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