Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934

Sompuram, Seshi R.; Torlakovic, Emina; Hart, Nils A 't; Vani, Kodela; Bogen, Steven A.

doi:10.1038/s41379-021-00884-w

Cited by 20 publications

(16 citation statements)

References 27 publications

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“…Overall, cytologic specimens appear to be acceptable specimens for PD‐L1 analysis especially when formalin fixed paraffin embedded cell block specimens are evaluated using the TPS for evaluation 9–13,20,22,24,34–70 …”

Section: Discussionmentioning

confidence: 99%

“…Quantitative comparison of PD-L1 immunohistochemistry assays with standard reference materialWhile non-quantitative evaluation of immunohistochemically stained specimens can be adequately controlled by appropriate similarly processed known positive and known negative specimens, quantitative and semi-quantitative assays for antigens such as estrogen receptor, progesterone receptor, and PD-L1 requires a more appropriate standard reference material. Sompuram et al69 have discussed the need for such a standard reference material. They demonstrated the utility of calibrators traceable to the National Institute of Standards and Technology (NIST) standard reference material 1934.…”

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confidence: 99%

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PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

Layfield

Zhang²,

Esebua

2022

Diagnostic Cytopathology

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Background: Immunotherapy based on disruption of the PD-1/PD-L1 axis is standard of care for many high stage malignancies including melanomas, non-small cell carcinomas of the lung, triple negative breast carcinomas, and squamous cell carcinomas of the head and neck. Eligibility for immunotherapy requires immunohistochemical assessment of PD-L1 expression. Currently, many high stage malignancies are diagnosed by cytology and cytologic material is the only specimen available for ancillary testing. Formal guidelines do not currently exist defining the optimal specimen type, antibody to be used or the best scoring system for cytologic material. Significant information has been published for PD-L1 testing of pulmonary specimens but much less data exists for the reproducibility, accuracy and best practices for material obtained from other body sites and types of malignancy. Methods:We searched the PubMed data base for manuscripts relating to PD-L1 testing of cytologic specimens. The search period was between 2016 and 2022. The search terms used were PD-L1, cytology, FNA, immunotherapy, immunohistochemistry, immunocytochemistry, cytology-histology correlation. Cross referencing techniques were used to screen for the most relevant manuscripts. The abstracts of these were then reviewed for final data collection and analysis.Results: A total of 86 studies were identified conforming to study relevancy. These were reviewed in their entirety by two authors (LJL, TZ) for extraction of data. The majority of studies involved pulmonary specimens (79) with three relating to PD-L1 testing of head and neck cytologic specimens and one each for PD-L1 testing of cytology specimens from melanomas, pancreas, pleural fluids, and triple negative breast carcinomas. While smears could be used, most studies found cell blocks optimal for testing.Summary: Currently, four drugs are approved for immunotherapy based on PD-L1 status. These drugs require specific antibody clones as well as scoring systems. Scoring systems and cut points vary with the type of neoplasm being treated. Cytology specimens from the lung, head and neck and melanomas can all be used for PD-L1 testing with good agreement with corresponding histology specimens.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

Layfield

Zhang²,

Esebua

2022

Diagnostic Cytopathology

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“…demonstrated that SP142 is characterized by a very high LOD compared to other approved and laboratory-developed test (LDT) assays and therefore is less sensitive. In particular, these authors showed that SP263 and SP142 do not show overlap in their dynamic range while 22C3 shows little overlap with the analytical performance of SP142 ( 27 ). These data explain the inability to harmonize the SP142 assay with either the SP263 or the 22C3 assay.…”

Section: Discussionmentioning

confidence: 99%

Comparison of three validated PD-L1 immunohistochemical assays in urothelial carcinoma of the bladder: interchangeability and issues related to patient selection

Munari

Querzoli²,

Brunelli

et al. 2022

Front. Immunol.

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Different programmed cell death-ligand 1 (PD-L1) assays and scoring algorithms are being used in the evaluation of PD-L1 expression for the selection of patients for immunotherapy in specific settings of advanced urothelial carcinoma (UC). In this paper, we sought to investigate three approved assays (Ventana SP142 and SP263, and Dako 22C3) in UC with emphasis on implications for patient selection for atezolizumab/pembrolizumab as the first line of treatment. Tumors from 124 patients with invasive UC of the bladder were analyzed using tissue microarrays (TMA). Serial sections were stained with SP263 and SP142 on Ventana Benchmark Ultra and with 22C3 on Dako Autostainer Link 48. Stains were evaluated independently by two observers and scored using the combined positive score (CPS) and tumor infiltrating immune cells (IC) algorithms. Differences in proportions (DP), overall percent agreement (OPA), positive percent agreement (PPA), negative percent agreement (NPA), and Cohen κ were calculated for all comparable cases. Good overall concordance in analytic performance was observed for 22C3 and SP263 with both scoring algorithms; specifically, the highest OPA was observed between 22C3 and SP263 (89.6%) when using CPS. On the other hand, SP142 consistently showed lower positivity rates with high differences in proportions (DP) compared with 22C3 and SP263 with both CPS and IC, and with a low PPA, especially when using the CPS algorithm. In conclusion, 22C3 and SP263 assays show comparable analytical performance while SP142 shows divergent staining results, with important implications for the selection of patients for both pembrolizumab and atezolizumab.

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“…NIST has recently worked with a few academic centers and reagent manufacturers on a single-target basis for known predictive biomarkers (e.g., PD-L1, ER, p53— Atha et al, 2010 ; Torlakovic et al, 2021 ; Sompuram et al, 2022 ) for the creation of tools linked to international standards enabling IHC measurement traceability and their validation by IPT/EQA programs. A consensus call supported by CAP, NIST, and FDA to develop a HER2 standard reference material occurred prior but no test standard emerged ( Hammond et al, 2003 ).…”

Section: Safety and Quality Standardsmentioning

confidence: 99%

Companion diagnostic requirements for spatial biology using multiplex immunofluorescence and multispectral imaging

Locke

Hoyt

2023

Front. Mol. Biosci.

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Immunohistochemistry has long been held as the gold standard for understanding the expression patterns of therapeutically relevant proteins to identify prognostic and predictive biomarkers. Patient selection for targeted therapy in oncology has successfully relied upon standard microscopy-based methodologies, such as single-marker brightfield chromogenic immunohistochemistry. As promising as these results are, the analysis of one protein, with few exceptions, no longer provides enough information to draw effective conclusions about the probability of treatment response. More multifaceted scientific queries have driven the development of high-throughput and high-order technologies to interrogate biomarker expression patterns and spatial interactions between cell phenotypes in the tumor microenvironment. Such multi-parameter data analysis has been historically reserved for technologies that lack the spatial context that is provided by immunohistochemistry. Over the past decade, technical developments in multiplex fluorescence immunohistochemistry and discoveries made with improving image data analysis platforms have highlighted the importance of spatial relationships between certain biomarkers in understanding a patient’s likelihood to respond to, typically, immune checkpoint inhibitors. At the same time, personalized medicine has instigated changes in both clinical trial design and its conduct in a push to make drug development and cancer treatment more efficient, precise, and economical. Precision medicine in immuno-oncology is being steered by data-driven approaches to gain insight into the tumor and its dynamic interaction with the immune system. This is particularly necessary given the rapid growth in the number of trials involving more than one immune checkpoint drug, and/or using those in combination with conventional cancer treatments. As multiplex methods, like immunofluorescence, push the boundaries of immunohistochemistry, it becomes critical to understand the foundation of this technology and how it can be deployed for use as a regulated test to identify the prospect of response from mono- and combination therapies. To that end, this work will focus on: 1) the scientific, clinical, and economic requirements for developing clinical multiplex immunofluorescence assays; 2) the attributes of the Akoya Phenoptics workflow to support predictive tests, including design principles, verification, and validation needs; 3) regulatory, safety and quality considerations; 4) application of multiplex immunohistochemistry through lab-developed-tests and regulated in vitro diagnostic devices.

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Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934

Cited by 20 publications

References 27 publications

PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

Comparison of three validated PD-L1 immunohistochemical assays in urothelial carcinoma of the bladder: interchangeability and issues related to patient selection

Companion diagnostic requirements for spatial biology using multiplex immunofluorescence and multispectral imaging

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