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Poster display session

2139 - Optimized protocols to determine PD-L1 expression on tumor tissue and cytology samples from non–small cell lung cancer (NSCLC) patients using the 22C3 antibody with various immunohistochemistry (IHC) autostainers


10 Sep 2017


Poster display session


Marius Ilie


Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376


M. Ilie1, S. Khambata-Ford2, C. Copie-Bergman3, L. Huang4, R. Mogg2, J. Juco2, V. Hofman5, P. Hofman6

Author affiliations

  • 1 Oncology, Université Côte d’Azur, 06100 - Nice/FR
  • 2 Oncology, Merck & Co., Inc., Kenillworth/US
  • 3 Oncology, AP-HP, Groupe Henri Mondor-Albert Chenevier, Universite Paris-Est, Faculte de Médecine, INSERM, Unité U955, Créteil/FR
  • 4 Bards, Merck & Co., Inc., Kenillworth/US
  • 5 Laboratory Of Clinical And Experimental Pathology, Hospital-related Biobank (bb-0033-00025), Cnrs, Inserm, Institute Of Research On Cancer And Ageing Of Nice (ircan), Fhu Oncoage, Team 3, Université Côte d'Azur, Pasteur Hospital, FHU OncoAge, Nice/FR
  • 6 Oncology, Université Côte d'Azur, Pasteur Hospital, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice (IRCAN), FHU OncoAge, Nice/FR


Abstract 2139


Pembrolizumab (pembro) is approved for treatment of PD-L1–expressing NSCLC in both treatment-naive patients with a PD-L1 expression tumor proportion score (TPS) ≥50% and previously treated patients with a PD-L1 TPS ≥1%. Testing for PD-L1 expression is mostly carried out using the PD-L1 IHC 22C3 pharmDx companion diagnostic test on the Dako Autostainer Link 48 (ASL48) platform. We developed optimized protocols for laboratory-developed tests (LDTs) that use the 22C3 antibody (Ab) concentrate on more widely available IHC autostainers for tumor tissue. We are also developing LDT protocols for cytology specimens.


PD-L1 expression was evaluated using the 22C3 Ab concentrate on 3 commercially available autostainers: ASL48, Ventana BenchMark ULTRA, and Leica BOND-III. Staining results were compared with the PD-L1 IHC 22C3 pharmDx kit on the ASL48 platform. PD-L1 expression was evaluated in tonsil specimens and a training set of 3 NSCLC specimens. Optimized protocols were validated in 120 NSCLC tumor tissue specimens. Cytology staining is being evaluated in 70 cell blocks from bronchial washes and pleural effusions with >100 tumor cells using the 22C3 Ab concentrate and optimized protocols.


Protocols for LDTs were established on both BenchMark ULTRA and ASL48; the BOND-III autostainer protocol could not be optimized without a prohibitively high concentration of 22C3 Ab. Intraclass correlation coefficients, which measure the correlation of TPS score as a continuous variable, were 98.7% to 99.9% for the 22C3 Ab concentrate on the ASL48 and ULTRA platforms relative to the PD-L1 IHC 22C3 pharmDx kit on the ASL48. Interpathologist agreement was high for both LDTs and for the PD-L1 IHC 22C3 pharmDx kit. Optimized protocols for evaluation of PD-L1 expression in cytology specimens will also be presented.


Optimized protocols to determine PD-L1 expression in tumor tissue and cytology specimens using the 22C3 Ab concentrate on multiple autostainer platforms will expand the ability of laboratories to assess eligibility of patients with NSCLC for treatment with pembro in a reliable and reproducible manner.

Clinical trial identification

Legal entity responsible for the study

Merck & Co., Inc., Kenilworth, New Jersey, USA


Merck & Co., Inc., Kenilworth, New Jersey, USA


S. Khambata-Ford: Employment with Merck; stock ownership with Bristol-Myers Squibb. L. Huang: Employment with Merck; stock ownership with Merck and GSK R. Mogg: Employment with Merck Sharpe and Dohme; stock ownership with Merck Sharpe and Dohme J. Juco: Employment with Merck & Co., Inc.; stock ownership with Merck, Illumina, and Regeneron All other authors have declared no conflicts of interest.

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