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Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using "PD-L1" as a search term for 01/01/2015 to 31/08/2018, with limitations "English" and "human". 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.

Citation

Emina Torlakovic, Hyun J Lim, Julien Adam, Penny Barnes, Gilbert Bigras, Anthony W H Chan, Carol C Cheung, Jin-Haeng Chung, Christian Couture, Pierre O Fiset, Daichi Fujimoto, Gang Han, Fred R Hirsch, Marius Ilie, Diana Ionescu, Chao Li, Enrico Munari, Katsuhiro Okuda, Marianne J Ratcliffe, David L Rimm, Catherine Ross, Rasmus Røge, Andreas H Scheel, Ross A Soo, Paul E Swanson, Maria Tretiakova, Ka F To, Gilad W Vainer, Hangjun Wang, Zhaolin Xu, Dirk Zielinski, Ming-Sound Tsao. Interchangeability" of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy. Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc. 2020 Jan;33(1):4-17

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PMID: 31383961

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