PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project Fred R. Hirsch, MD, PhD,

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PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project Fred R. Hirsch, MD, PhD,

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PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project Fred R. Hirsch, MD, PhD, Abigail McElhinny, PhD, Dave Stanforth, MBA, James Ranger-Moore, PhD, Malinka Jansson, MA, Karina Kulangara, PhD, William Richardson, BA, Penny Towne, BS, MBA, Debra Hanks, MD, Bharathi Vennapusa, MD, Amita Mistry, MD, Rasika Kalamegham, PhD, Steve Averbuch, MD, James Novotny, PhD, Eric Rubin, MD, Kenneth Emancipator, MD, Ian McCaffery, PhD, J. Andrew Williams, PhD, Jill Walker, PhD, John Longshore, PhD, Ming Sound Tsao, MD, Keith M. Kerr, MB, FRCPath Journal of Thoracic Oncology Volume 12, Issue 2, Pages 208-222 (February 2017) DOI: 10.1016/j.jtho.2016.11.2228 Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 BluePrint Project: materials and methods workflow. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Analytical comparison of percentage tumor cell and immune cell staining, by case, for each assay. Data points represent the mean score from three pathologists for each assay on each case. Superimposed points indicate identical values. No clinical diagnostic cut-off was applied. ‘Best fit’ colored curves allow comparison of score range between the four assays. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 3 Pairwise associations for percentage tumor or immune cell staining presented by reader. Each scatter plot shows the pair-wise relationship of percentage tumor (A) or immune (B) cell scoring on 38 cases by three independent observers. The data is presented by assay pairs in each plot such that the top-left scatter plot illustrates the pair-wise data (on a scale of 1–100%) between assays 22C3 and 28-8. The differently-shaped colored symbols represent data of individual readers on the 38 cases, and the corresponding colored regression lines show the correlation between each assay pair based on the scores for each reader. For 4A as an example, the circled red triangle in the upper left plot is for a case that was scored at 40% tumor cells positive with 22C3 and 30% tumor cells positive with 28-8 by observer Path_SP142. Some points are superimposed on the plots but there are 38 data points per observer in all plots. A 45-degree regression line indicates perfect correlation and superimposed regression lines indicate low inter-observer variability. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 4 Comparison of cases allocated above or below clinical assay thresholds. Scoring applied according to threshold for the assay. Heat map (A) and Venn diagram (B) show the diagnostic PD-L1 classification of the 38 cases stained with each of the four PD-L1 IHC systems and scored above and below their respective clinical threshold. The map in (A) illustrates the diagnostic outcome (concordance/discordance) for each case (rows 1–38 shown on the right hand side) across the various assays/scoring algorithm combinations. The light gray color corresponds to PD-L1 levels below each respective threshold while the dark gray color corresponds to PD-L1 levels above each respective threshold. Five cases out of the total 38 show concordance below all threshold values across all assay/algorithm combinations, while 19 cases show expression above all threshold values across all assay/algorithm combinations. The remaining 14 cases show a combination of discordant outcome across the various assay/algorithm combinations. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 5 Representative staining of tumor cells from weak or negative to strong staining on five representative NSCLC cases by the four PDL1 assays at 20X magnification (A, B, C, D, E, and F) and 10X (G). 22C3, 28-8 and SP263 assays appeared relatively similar in overall pattern and coverage of tumor cells (brown), while SP142 stained fewer tumor cells in the majority of cases. In A, B, C, D, E, and G representative staining of infiltrating immune cells are shown across a range of expression. Note that all four assays detected immune cells to varying degrees. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 5 Representative staining of tumor cells from weak or negative to strong staining on five representative NSCLC cases by the four PDL1 assays at 20X magnification (A, B, C, D, E, and F) and 10X (G). 22C3, 28-8 and SP263 assays appeared relatively similar in overall pattern and coverage of tumor cells (brown), while SP142 stained fewer tumor cells in the majority of cases. In A, B, C, D, E, and G representative staining of infiltrating immune cells are shown across a range of expression. Note that all four assays detected immune cells to varying degrees. Journal of Thoracic Oncology 2017 12, 208-222DOI: (10.1016/j.jtho.2016.11.2228) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions