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Review
. 2023 Oct:190:104103.
doi: 10.1016/j.critrevonc.2023.104103. Epub 2023 Aug 16.

Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey

Nicola Fusco  1 , Mariia Ivanova  2 , Chiara Frascarelli  3 , Carmen Criscitiello  4 , Bruna Cerbelli  5 , Maria Gemma Pignataro  5 , Angelina Pernazza  5 , Elham Sajjadi  3 , Konstantinos Venetis  2 , Giulia Cursano  2 , Fabio Pagni  6 , Camillo Di Bella  7 , Marina Accardo  8 , Michelina Amato  9 , Paolo Amico  10 , Caterina Bartoli  11 , Giuseppe Bogina  12 , Laura Bortesi  12 , Renzo Boldorini  13 , Sara Bruno  14 , Daniela Cabibi  15 , Pietro Caruana  16 , Emanuele Dainese  17 , Elisa De Camilli  2 , Vladimiro Dell'Anna  18 , Loren Duda  19 , Carmela Emmanuele  20 , Giuseppe Nicolò Fanelli  21 , Bethania Fernandes  22 , Gerardo Ferrara  23 , Letizia Gnetti  20 , Alessandra Gurrera  24 , Giorgia Leone  25 , Raffaella Lucci  26 , Cristina Mancini  20 , Grazia Marangi  27 , Mauro G Mastropasqua  28 , Lorenzo Nibid  29 , Sandra Orrù  30 , Maria Pastena  31 , Monica Peresi  32 , Letizia Perracchio  33 , Angela Santoro  34 , Vania Vezzosi  35 , Claudia Zambelli  36 , Valeria Zuccalà  37 , Antonio Rizzo  25 , Leopoldo Costarelli  9 , Francesca Pietribiasi  38 , Alfredo Santinelli  39 , Cristian Scatena  21 , Giuseppe Curigliano  40 , Elena Guerini-Rocco  3 , Maurizio Martini  41 , Paolo Graziano  42 , Isabella Castellano  43 , Giulia d'Amati  5
Affiliations
Review

Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey

Nicola Fusco et al. Crit Rev Oncol Hematol. 2023 Oct.

Abstract

Pembrolizumab has received approval as a first-line treatment for unresectable/metastatic triple-negative breast cancer (mTNBC) with a PD-L1 combined positive score (CPS) of ≥ 10. However, assessing CPS in mTNBC poses challenges. Firstly, it represents a novel analysis for breast pathologists. Secondly, the heterogeneity of PD-L1 expression in mTNBC further complicates the assessment. Lastly, the lack of standardized assays and staining platforms adds to the complexity. In KEYNOTE trials, PD-L1 expression was evaluated using the IHC 22C3 pharmDx kit as a companion diagnostic test. However, both the 22C3 pharmDx and VENTANA PD-L1 (SP263) assays are validated for CPS assessment. Consequently, assay-platform choice, staining conditions, and scoring methods can significantly impact the testing outcomes. This consensus paper aims to discuss the intricacies of PD-L1 CPS testing in mTNBC and provide practical recommendations for pathologists. Additionally, we present findings from a nationwide Italian survey elucidating the state-of-the-art in PD-L1 CPS testing in mTNBC.

Keywords: 22C3; Biomarkers; Breast cancer; CPS; Immunotherapy; PD-L1; SP263; TNBC.

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Conflict of interest statement

Declaration of Competing Interest Nicola Fusco has received honoraria for consulting, advisory role, speaker bureau, travel, and/or research grants from Merck Sharp & Dohme (MSD), Novartis, AstraZeneca, Roche, Daiichi Sankyo, GlaxoSmithKline (GSK), Gilead, Diaceutics, Adicet Bio, and Sermonix. Mariia Ivanova from Agilent Technologies Denmark ApS. Carmen Criscitiello reports personal fees for consulting, advisory role, and speakers’ bureau from Lilly, Roche, Novartis, MSD, Seagen, Gilead, Daiichi Sankyo, AstraZeneca, and Pfizer. Bruna Cerbelli from MSD and Novartis. Fabio Pagni from MSD, Novartis, Roche, and Amgen. Mauro Mastropasqua from Exact Sciences. Alfredo Santinelli from Roche-Ventana, Novartis, Astrazeneca, Amgen. Giuseppe Curigliano has received honoraria for speaker’s engagement: Roche, Seattle Genetics, Novartis, Lilly, Pfizer, Foundation Medicine, NanoString, Samsung, Celltrion, BMS, MSD; Honoraria for providing consultancy: Roche, Seattle Genetics, NanoString; Honoraria for participating in Advisory Board: Roche, Lilly, Pfizer, Foundation Medicine, Samsung, Celltrion, Mylan; Honoraria for writing engagement: Novartis, BMS; Honoraria for participation in Ellipsis Scientific Affairs Group; Institutional research funding for conducting phase I and II clinical trials: Pfizer, Roche, Novartis, Sanofi, Celgene, Servier, Orion, AstraZeneca, Seattle Genetics, AbbVie, Tesaro, BMS, Merck Serono, Merck Sharp Dome, Janssen-Cilag, Philogen, Bayer, Medivation, Medimmune. Elena Guerini-Rocco from Thermo Fisher Scientific, Novartis, AstraZeneca, Roche, Biocartis, Exact Science, GSK, and Illumina. Paolo Graziano Consulting/Honoraria from Eli-Lilly, Pfizer, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, MSD, Amgen. Giulia d’Amati from MSD, Roche, Astrazeneca, Daiichi Sankyo. These companies had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and/or in the decision to publish the results. All other authors declare no potential conflicts of interest.

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