{"entity": "publication", "iuid": "63e43d090aa744c4858830f4443c5509", "timestamp": "2026-08-26T23:02:02.569Z", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/63e43d090aa744c4858830f4443c5509.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/63e43d090aa744c4858830f4443c5509"}}, "title": "PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project.", "authors": [{"family": "Tsao", "given": "Ming Sound", "initials": "MS"}, {"family": "Kerr", "given": "Keith M", "initials": "KM"}, {"family": "Kockx", "given": "Mark", "initials": "M"}, {"family": "Beasley", "given": "Mary-Beth", "initials": "MB"}, {"family": "Borczuk", "given": "Alain C", "initials": "AC"}, {"family": "Botling", "given": "Johan", "initials": "J"}, {"family": "Bubendorf", "given": "Lukas", "initials": "L"}, {"family": "Chirieac", "given": "Lucian", "initials": "L"}, {"family": "Chen", "given": "Gang", "initials": "G"}, {"family": "Chou", "given": "Teh-Ying", "initials": "TY"}, {"family": "Chung", "given": "Jin-Haeng", "initials": "JH"}, {"family": "Dacic", "given": "Sanja", "initials": "S"}, {"family": "Lantuejoul", "given": "Sylvie", "initials": "S"}, {"family": "Mino-Kenudson", "given": "Mari", "initials": "M"}, {"family": "Moreira", "given": "Andre L", "initials": "AL"}, {"family": "Nicholson", "given": "Andrew G", "initials": "AG"}, {"family": "Noguchi", "given": "Masayuki", "initials": "M"}, {"family": "Pelosi", "given": "Giuseppe", "initials": "G"}, {"family": "Poleri", "given": "Claudia", "initials": "C"}, {"family": "Russell", "given": "Prudence A", "initials": "PA"}, {"family": "Sauter", "given": "Jennifer", "initials": "J"}, {"family": "Thunnissen", "given": "Erik", "initials": "E"}, {"family": "Wistuba", "given": "Ignacio", "initials": "I"}, {"family": "Yu", "given": "Hui", "initials": "H"}, {"family": "Wynes", "given": "Murry W", "initials": "MW"}, {"family": "Pintilie", "given": "Melania", "initials": "M"}, {"family": "Yatabe", "given": "Yasushi", "initials": "Y"}, {"family": "Hirsch", "given": "Fred R", "initials": "FR"}], "type": "clinical trial, phase ii", "published": "2018-09-00", "journal": {"title": "J Thorac Oncol", "issn": "1556-1380", "volume": "13", "issue": "9", "pages": "1302-1311", "issn-l": null}, "abstract": "The Blueprint (BP) Programmed Death Ligand 1 (PD-L1) Immunohistochemistry Comparability Project is a pivotal academic/professional society and industrial collaboration to assess the feasibility of harmonizing the clinical use of five independently developed commercial PD-L1 immunohistochemistry assays. The goal of BP phase 2 (BP2) was to validate the results obtained in BP phase 1 by using real-world clinical lung cancer samples.\n\nBP2 were conducted using 81 lung cancer specimens of various histological and sample types, stained with all five trial-validated PD-L1 assays (22C3, 28-8, SP142, SP263, and 73-10); the slides were evaluated by an international panel of pathologists. BP2 also assessed the reliability of PD-L1 scoring by using digital images, and samples prepared for cytological examination. PD-L1 expression was assessed for percentage (tumor proportional score) of tumor cell (TC) and immune cell areas showing PD-L1 staining, with TCs scored continuously or categorically with the cutoffs used in checkpoint inhibitor trials.\n\nThe BP2 results showed highly comparable staining by the 22C3, 28-8 and SP263 assays; less sensitivity with the SP142 assay; and higher sensitivity with the 73-10 assay to detect PD-L1 expression on TCs. Glass slide and digital image scorings were highly concordant (Pearson correlation >0.96). There was very strong reliability among pathologists in TC PD-L1 scoring with all assays (overall intraclass correlation coefficient [ICC] = 0.86-0.93), poor reliability in IC PD-L1 scoring (overall ICC = 0.18-0.19), and good agreement in assessing PD-L1 status on cytological cell block materials (ICC = 0.78-0.85).\n\nBP2 consolidates the analytical evidence for interchangeability of the 22C3, 28-8, and SP263 assays and lower sensitivity of the SP142 assay for determining tumor proportion score on TCs and demonstrates greater sensitivity of the 73-10 assay compared with that of the other assays.", "doi": "10.1016/j.jtho.2018.05.013", "pmid": "29800747", "labels": [], "xrefs": [{"db": "mid", "key": "NIHMS1633921"}, {"db": "pmc", "key": "PMC8386299"}, {"db": "pii", "key": "S1556-0864(18)30626-9"}], "notes": [], "created": "2026-08-21T11:24:24.103Z", "modified": "2026-08-21T11:24:24.154Z"}