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- W2802700711 abstract "Background: With the approval of the PD1 Inhibitor pembrolizumab forfirst line treatment of PD-L1+ NSCLC, PD-L1 testing by immunohistochemistry(IHC) has become a necessity. However, the DAKO AutostainerAS48 for the FDA approved DAKO 22C3 PharmDX assay (22C3PhDX) isnot available in Switzerland. The goal of this study was to cross validate theconcentrated 22C3 antibody on the Ventana BenchMark Ultra and LeicaBond immunostainers.Methods: We developed protocols for the concentrated anti-PD-L1 22C3antibody for both platforms. 22C3PhDX on the AS48 was used as standard.A tissue microarray was constructed from 23 NSCLC. Empty sectionsand the antibody were distributed to 16 participants to be stainedon the Ventana (8) and/or Leica (12) platform. Central scoring and statisticalevaluation was performed in Basel. We also tested the performanceof the Ventana SP263 assay and Cell signaling E1L3N antibody in selectedcenters using local protocols.Results: There was strong variability of 22C3 PD-L1 tumor cell stainingas a continuous variable for both platforms. Categorical PD-L1 staining(0–49% vs. 50–100%) did not significantly differ between the centers usingVentana, whereas data from Leica remained highly variable (p<0.001).Staining on Leica was generally weaker than on Ventana compared to 22C3PhDX making scoring more tiresome and requiring a higher magnification.SP263 (4 centers) was highly concordant with 22C3 on Ventanaand with P22C3PhDX, whereas E1L3N (3 centers) was strongly variable.Conclusions: PD-L1 IHC using a standardized protocol for 22C3 antibodyon Ventana is feasible and provides satisfactory results in most centers,and also the approved SP263 assays is confirmed as a good alternativeto 22C3PhDx. 22C3 PD-L1 IHC on Bond is currently not recommendeddue to major staining variability between centers. Local fine-tuning ofIHC protocols and participation in ring trials are critical when laboratorydeveloped 22C3 IHC is used." @default.
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- W2802700711 date "2017-10-20" @default.
- W2802700711 modified "2023-09-24" @default.
- W2802700711 title "01: PD-L1 testing using concentrated 22C3 antibody: Results of the Swiss cross-validation study" @default.
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