Ultraview License Open Archive

Ultraview License Open Archive

Vainer MD, PhD c d Show more Share Cite Get rights and content Under an Elsevier user license open archive Abstract Introduction Immunotherapy is a novel treatment for lung cancer.

Pembrolizumab (Merck Sharp and Dohme, Kenilworth, NJ) is a monoclonal antibody against programmed cell death 1 that has been approved for use with NSCLC together with a companion diagnostic by Dako (Carpinteria, CA).

Ventanas BenchMark XT (Ventana Medical Systems, Tucson, AZ) is a widely used immunohistochemical (IHC) platform.

However, data on its reliability and reproducibility with the 22C3 antibody are scant.

Methods We performed a comprehensive calibration of 22C3 programmed cell death ligand 1 (PD-L1) staining on the BenchMark XT platform using Dakos prediluted 22C3 antiPD-L1 primary antibody with two of Ventanas detection systems.

Forty-one random cases of NSCLC were then independently evaluated by two pathologists.

The scores obtained with the two 22C3 Ventana assays were compared with those obtained using the Dako 22C3 IHC platform.

Results The Dako IHC platform stratified eight, seven, and 26 cases as being strongly positive, weakly positive, and negative for PD-L1, respectively, whereas 36 of 41 cases (87.8) had the same results with Ventanas UltraView 22C3 protocol (Pearsons correlation score 0.91, p p Conclusions The results of this study demonstrate that the same PD-L1 IHC algorithm can be reliably applied to Ventanas BenchMark XT platform.

Furthermore, we were able to detect all of the strongly positive cases with high interobserver and intraobserver agreement by using the Ventana platform.

These findings suggest that the Ventana platform can be used to stratify patients for pembrolizumab-based immunotherapy.

Previous article in issue Next article in issue Keywords PD-L1 IHC Dako Ventana Harmonization Recommended articles Citing articles (0) Disclosure: Dr.

Vainer reports grants, personal fees, nonfinancial support, fees for a Dako staining machine, and fees for travel and lecture from Merck Sharp and Dohme during the performance of the study; personal fees from Roche, and a grant from AstraZeneca, all unrelated to the submitted work.

Mrs. London reports receiving fees from Ventana Medical Systems (a member of the Roche Group) during the performance of the study that are unrelated to the submitted work.

View Abstract 2016 International Association for the Study of Lung Cancer.

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