Immunohistochemical assay for detecting expression of programmed death ligand 1 (pd-l1) in tumor tissue

a tumor and immunohistochemical technology, applied in the field of immunohistochemical, can solve the problems of poor prognosis, reduced overall survival irrespective of subsequent treatment, and correlated pd-l1 expression, and achieve the effect of facilitating standardization of pd-l1 expression quantification

Inactive Publication Date: 2016-03-24
MERCK SHARP & DOHME CORP
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  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0009]The inventors have surprisingly discovered that quantifying PD-L1 expression using IHC analysis, beyond a simple binary positive/negative characterization, can provide valuable predictive information to identify patients who are more likely to respond to treatment with anti-PD-1 therapy. Furthermore, the inventors h

Problems solved by technology

In large sample sets of e.g. ovarian, renal, colorectal, pancreatic, liver cancers and melanoma it was shown that

Method used

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  • Immunohistochemical assay for detecting expression of programmed death ligand 1 (pd-l1) in tumor tissue
  • Immunohistochemical assay for detecting expression of programmed death ligand 1 (pd-l1) in tumor tissue
  • Immunohistochemical assay for detecting expression of programmed death ligand 1 (pd-l1) in tumor tissue

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embodiment 1

2. The process of embodiment 1, wherein the tumor sample is from a cancer selected from the group consisting of non-small cell lung carcinoma (NSCLC), head and neck squamous carcinoma, and transitional bladder carcinoma, and the process further comprises designating the tumor sample as positive or negative for PD-L1 expression, wherein

[0129]the tumor sample is designated as positive for PD-L1 expression if either of the MHS or the MPS is greater than zero, and

[0130]the tumor sample is designated as negative for PD-L1 expression if the MHS is zero or the MPS is zero.

embodiment 2

3. The process of embodiment 2, wherein the cancer is NSCLC.

4. The process of any of the above embodiments, wherein only the MPS is assigned.

5. The process of embodiment 1 or 2, further comprising:

[0131]examining the stroma surrounding each tumor nest for the presence or absence within the stroma of a band of membrane-stained cells, and

[0132]assigning to the tissue section a stroma score of positive if the band is detected in the stroma surrounding at least one tumor nest, or

[0133]assigning to the tissue section a stroma score of negative if the band is not detected in the tissue section.

embodiment 5

6. The process of embodiment 5, wherein the tumor sample is from a cancer selected from the group consisting of non-small cell lung carcinoma (NSCLC), head and neck squamous carcinoma, and transitional bladder carcinoma, and the process further comprises designating the tumor sample as positive or negative for PD-L1 expression,

[0134]wherein the tumor sample is designated as positive for PD-L1 expression if the tissue section has any one or more of the following score assignments:[0135](i) the stroma score is positive,[0136](ii) the MHS greater than zero, and[0137](iii) the MPS is greater than zero, and

[0138]wherein the tumor sample is designated as negative for PD-L1 expression if the tissue section has any one or more of the following score assignments:[0139](iv) the stroma score is negative and the MHS is zero;[0140](v) the stroma score is negative and the MPS is zero; and[0141](vi) the stroma score is negative, the MHS is zero and the MPS is zero.

7. The process of embodiment 5, w...

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Abstract

The present disclosure provides processes for describing and quantifying the expression of human programmed death ligand-1 (PD-L1) in tumor tissue sections as detected by immunohistochemical assay using an antibody that specifically binds to PD-L1. The results generated using these processes have a variety of experimental, diagnostic and prognostic applications.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the quantitation of PD-L1 expression in animal tissue samples by immunohistochemical (IHC) assay. The invention also relates to the identification of PD-L1 expression levels that correlate with response of cancer patients to therapy with antagonists of Programmed Death 1 (PD-1).BACKGROUND OF THE INVENTION[0002]PD-L1 is a cell surface glycoprotein that is one of two known ligands for Programmed Death 1 (PD-1), which is recognized as an important player in immune regulation and the maintenance of peripheral tolerance. Expression of PD-L1 has been observed on the surface of a variety of immune cells, including naive lymphocytes and activated B and T cells, monocytes and dendritic cells (Id.). Furthermore, PD-L1 mRNA is expressed by non-lymphoid tissues including vascular endothelial cells, epithelial cells, muscle cells, and in tonsil and placental tissue. See, e.g., Keir, M. E. et al., Annu Rev Immunol. 26:677-704 (2008); Sh...

Claims

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Application Information

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IPC IPC(8): G01N33/574
CPCG01N33/57492G01N2800/52G01N2333/70596G01N33/57415G01N33/57423G01N33/5743
Inventor DOLLED-FILHART, MARISAEMANCIPATOR, JR., KENNETHLYNCH, FRANKPIERCE, ROBERT, H.WU, DIANNA
Owner MERCK SHARP & DOHME CORP
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