Clinical performance of artificial intelligence-powered annotation of tumor cell PD-L1 expression for treatment of immune-checkpoint inhibitor (ICI) in advanced non-small cell lung cancer (NSCLC).

Authors

null

Hyojin Kim

Department of Pathology, Seoul National University Bundang Hospital, Seongnam, South Korea

Hyojin Kim , Sangjoon Choi , Seokhwi Kim , Jaehong Aum , Sergio Pereira , Seonwook Park , Minuk Ma , Seunghwan Shin , Kyunghyun Paeng , Donggeun Yoo , Wonkyung Jung , Chan-Young Ock , Se-Hoon Lee , Jin-haeng Chung , Yoon-La Choi , Tony S. K. Mok

Organizations

Department of Pathology, Seoul National University Bundang Hospital, Seongnam, South Korea, Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Department of Pathology, Ajou University School of Medicine, Suwon, South Korea, Lunit Inc., Seoul, South Korea, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Department of Pathology and Translational Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong, China

Research Funding

Other
Lunit Inc

Background: Programmed death ligand 1 (PD-L1) expression is the standard biomarker for first line ICI in advanced NSCLC. However, manual evaluation of tumor proportion score (TPS) by pathologists has practical limitations including intra/inter-observer bias, variation in subjectivity on area of interest and intensive labor. We developed an artificial intelligence (AI)-powered TPS analyzer, namely Lunit SCOPE PD-L1, for objective annotation of tumor cell PD-L1 expression for prediction of ICI response in advanced NSCLC. Methods: Lunit SCOPE PD-L1 was developed by a total of 393,565 tumor cells annotated by board-certified pathologists for PD-L1 expression in 802 whole-slide images (WSI) stained by 22C3 pharmDx immunohistochemistry. A After excluding the in-house control tissue regions, the WSI were divided into patches, from which a deep learning-based model detected the location and PD-L1 positivity of tumor cells. The patch-level cell predictions were aggregated for TPS estimation. Clinical performance of the model was validated in an external cohort of 430 NSCLC tumor slides from patients treated with ≥ ICI at Seoul National University Bundang Hospital and Samsung Medical Center. Independent control TPS annotation of this external validation cohort was performed by three pathologists, and their consensus TPS was calculated by mean value of such. Results: AI-model (Lunit SCOPE PD-L1) predicts PD-L1-positive tumor cell with the area under the curves of 0.889 and PD-L1-negative tumor cells with that of 0.809 at cell-level analysis. At WSI-level, significant positive correlation was observed between TPS by AI model and control TPS by pathologists (Spearman coefficient = 0.9247, P< 0.001). Concordance rate between AI-model and control TPS by pathologists according to expression level of PD-L1 ≥ 50%, 1-49%, and < 1% status was 85.7%, 89.3%, and 52.4%, respectively. Median progression-free survival (mPFS) according to TPS by AI model ≥ 1% vs. < 1% were 2.8 vs. 1.7 months (hazard ratio, HR, 0.52, 95% confidence interval, CI, 0.38-0.71, P< 0.001). In contrast, mPFS according to control TPS was 2.8 vs. 2.1 months (HR 0.70, 95% CI 0.55-0.91, P< 0.001). Forty out of 84 patients (47.6%) annotated as control TPS < 1% by pathologists were considered as TPS ≥ 1% by AI-model and mPFS of this subgroup was 2.7 months. Conclusions: PD-L1 expression by AI-model correlates with PD-L1 expression by pathologists. Clinical performance of AI-model in WSI-level is comparable with assessment by pathologists. The AI-model can accurately predict tumor response and progression-free survival of ICI in advanced NSCLC.

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Biologic Correlates

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 9026)

DOI

10.1200/JCO.2021.39.15_suppl.9026

Abstract #

9026

Poster Bd #

Online Only

Abstract Disclosures