VENTANA PD-L1 (SP142) Assay

VENTANA PD-L1 (SP142) Assay
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VENTANA PD L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD L1 clone SP142 intended for use in the assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in the formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument.

Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies for the respective cutoffs listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay Indication for use Therapy Cutoff Urothelial Carcinoma TECENTRIQ ≥ 5% IC Triple-Negative Breast Carcinoma (TNBC) TECENTRIQ ≥ 1% IC

PD-L1 expression in ≥ 50% TC or ≥ 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).

Test results of this product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.

Non-Small Cell Lung Cancer
Urothelial Carcinoma
Triple Negative Breast Cancer
The PD-L1 immunologic checkpoint
About PD-L1

PD-L1 is a transmembrane protein that down-regulates immune responses through binding to its two inhibitory receptors, programmed death-1 (PD-1) and B7.1. PD-1 is an inhibitory receptor expressed on T cells following T-cell activation, which is sustained in states of chronic stimulation such as in chronic infection or cancer.1 Binding of PD-L1 with PD-1 inhibits T cell proliferation, cytokine production and cytolytic activity, leading to the functional inactivation or exhaustion of T cells. B7.1 is a molecule expressed on antigen presenting cells and activated T cells. PD-L1 binding to B7.1 on T cells and antigen presenting cells can mediate down-regulation of immune responses, including inhibition of T-cell activation and cytokine production.2 PD-L1 expression has been observed in immune cells and tumor cells.3,4 Aberrant expression of PD-L1 on tumor cells has been reported to impede anti-tumor immunity, resulting in immune evasion.1 Therefore, interruption of the PD-L1/PD-1 pathway represents an attractive strategy to reinvigorate tumor-specific T cell immunity suppressed by the expression of PD-L1 in the tumor microenvironment.

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References 
1 Blank, C and Mackensen, A, Contribution of the PD-L1/PD-1 pathway to T-cell exhaustion: an update on implications for chronic infections and tumor evasion. Cancer Immunol Immunother, 2007. 56(5): p. 739-745. 
2 Butte MJ, Keir ME, Phamduy TB, et al. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity. 2007;27(1):111-122. 
3 Dong H, Zhu G, Tamada K, Chen L. B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med. 1999;5(12):1365-1369. 
4 Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515(7528):563-567.

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References 
1 NCI Dictionary of Cancer Terms. Tumor microenvironment. http://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=561725 
2 AACR. The Function of Tumor Microenvironment in Cancer Progression. http://www.aacr.org/Meetings/Pages/MeetingDetail. aspx?EventItemID=73#.V6pCFPkrKaE 
3 Chen F, Zhuang X, Lin L, Yu P, Wang Y, Shi Y, Hu G, Sun Y.BMC Med. New horizons in tumor microenvironment biology: challenges and opportunities. 2015 Mar 5;13:45. doi: 10.1186/s12916-015-0278-7. 
4 Galon J1, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pagès C, Tosolini M, Camus M, Berger A, Wind P, Zinzindohoué F, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Pagès F. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006 Sep 29;313(5795):1960-4. 
5 Blank, C and Mackensen, A, Contribution of the PD-L1/PD-1 pathway to T-cell exhaustion: an update on implications for chronic infections and tumor evasion. Cancer Immunol Immunother, 2007. 56(5): p. 739-745). 
6 Ventana Medical Systems Inc. VENTANA PD-L1 (SP142) Assay. Package Insert. http://www.ventana.com/product/1827?type=2357

The tumor microenvironment
Plays a key role in tumor progression
What is the tumor microenvironment (TME)?

The tumor microenvironment (TME) consists of different cellular, including immune cells, and non-cellular components in and around the tumor. The TME has been recognized to play a significant role in tumor progression.1,2

Why is the TME important?

The TME shapes tumor evolution (whether the tumor regresses, develops resistance, evades the immune system and/or metastasizes) and consequently impacts patient outcomes.3 An association has been observed between the levels of tumor infiltrating immune cells, key components of the TME, and patient prognosis: a colorectal cancer study showed that higher levels of tumor infiltrating CD3+ immune cells were associated with better disease free survival.4

What is the role of PD-L1 in the TME?

Aberrant expression of PD-L1 on tumor cells has been reported to impede anti-tumor immunity, resulting in immune evasion.5 Therefore, interruption of the PD-L1/PD-1 pathway represents an attractive strategy to reinvigorate tumor-specific T cell immunity suppressed by the expression of PD-L1 in the TME. This approach has proven effective: PD-L1 expression on immune cells in the TME has been shown to identify urothelial cancer patients who are most likely to benefit from atezolizumab an anti-PD-L1 drug.6

Non-small cell lung cancer

Using the right test to determine PD-L1 status for immunotherapy options is important, and the VENTANA PD-L1 (SP142) Assay is the only FDA approved test for TECENTRIQ. This innovative assay is the first to evaluate patient PD-L1 expression using both tumor cell (TC) and tumor-infiltrating immune cell (IC) staining. Determining a patient’s PD-L1 expression level can give insight to the overall survival that may be achieved from TECENTRIQ.*

The VENTANA PD-L1 (SP142) Assay:

  • FDA approved to assess NSCLC patient treatment benefit from TECENTRIQ
  • Informative for the clinician of a patient’s potential overall survival
  • Novel scoring algorithm using PD-L1 staining in both TC and IC
  • Designed to enhance visual contrast of immune cell staining within the tumor microenvironment

The PD-L1 (SP142) Assay gives you the confidence to guide immunotherapy decisions in NSCLC.

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*All randomized patients in a NSCLC phase III study observed benefit from TECENTRIQ regardless of PD-L1 status.

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*In the US only available on the VENTANA BenchMark ULTRA Instrument.

Urothelial carcinoma

Using the right test to determine PD-L1 status for immunotherapy options is important. The VENTANA PD-L1 (SP142) Assay* is the first and only FDA approved test predictive for TECENTRIQ in urothelial carcinoma (UC) patients. This novel assay is also the first to evaluate patient PD-L1 expression using immune cell staining and scoring within the tumor microenvironment, providing you with information that can guide immunotherapy decisions.

The VENTANA PD-L1 (SP142) Assay:

  • FDA approved to predict UC patient response to TECENTRIQ
  • Designed to enhance visual contrast of immune cell staining within the tumor microenvironment
  • Stains PD-L1 in both tumor cells (TC) and tumor-infiltrating immune cells (IC)
Triple Negative Breast Cancer

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.®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.The VENTANA PD-L1 (SP142) Assay:

  • FDA approved to predict TNBC patients eligible for treatment with TECENTRIQ
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1. TECENTRIQ Prescribing Information
2. Ventana Product Document Library. Package Insert. VENTANA PD-L1 (SP142) Assay.

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