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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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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

The patent text explains that analyzing the expression of a protein called PD-L1 can help predict which patients will benefit from treatment with anti-PD-1 therapy. The inventors have developed a scoring process to standardize the measurement of PD-L1 expression across different laboratories. This scoring process produces a quantitative measure of PD-L1 expression that can be used to select patients for treatment.

Problems solved by technology

In large sample sets of e.g. ovarian, renal, colorectal, pancreatic, liver cancers and melanoma it was shown that PD-L1 expression correlated with poor prognosis and reduced overall survival irrespective of subsequent treatment.

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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Experimental program
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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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