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Comparison of PD ‐L1 immunohistochemistry assays and response to PD ‐1/L1 inhibitors in advanced non‐small‐cell lung cancer in clinical practice
Author(s) -
Villaruz Liza C,
Ancevski Hunter Katerina,
Kurland Brenda F,
Abberbock Shira,
Herbst Cameron,
Dacic Sanja
Publication year - 2019
Publication title -
histopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.626
H-Index - 124
eISSN - 1365-2559
pISSN - 0309-0167
DOI - 10.1111/his.13729
Subject(s) - atezolizumab , pembrolizumab , medicine , concordance , lung cancer , pd l1 , nivolumab , confidence interval , response evaluation criteria in solid tumors , oncology , quartile , pathology , clinical trial , cancer , immunotherapy , phases of clinical research
Aims Several studies have demonstrated analytical comparability between different PD ‐L1 assays, but their clinical validity in non‐small‐cell lung cancer in terms of response to treatment outside clinical trials has not been established. The aim of our study is to assess the analytical performance of laboratory‐developed tests for Ventana SP263 and Agilent/Dako 22C3, and to investigate the association between PD‐L1 assays and response to PD‐1/L1 inhibitors. Methods and results PD‐L1 SP263 and 22C3 assays were performed on 302 consecutive non‐small‐cell lung carcinoma samples Both assays were optimised for use on the automated Ventana BenchMark Ultra platform. Scoring algorithms for staining of the tumour cells using the established cut‐offs were applied to all samples. Best overall response ( BOR ) for 44 patients treated with either nivolumab, pembrolizumab or atezolizumab were assessed using recist version 1.1 and correlated with PD ‐L1 assay results. Assays showed good agreement, with a concordance correlation coefficient of 0.86 [95% confidence interval ( CI ) = 0.82–0.90)]. Comparing the assays using cut‐offs of 1%, 5%, 10%, 1–49% and ≥50% showed an association between the two assays ( P < 0.0001). The SP 263 10% cut‐off ( P = 0.032) was associated with BOR , whereas the 1% ( P = 0.087) and 5% ( P = 0.051) cut‐offs were not. In contrast 22C3, cut‐offs of 1% ( P = 0.019), 5% ( P = 0.025) and 10% ( P = 0.014) were all associated with BOR . Conclusions The SP 263 and 22C3 LDT s demonstrated good analytical concordance, and correlation with response to PD ‐1/L1 inhibitors.