• Ji Hyun Park, Gun Lyung You, Myung-Ju Ahn, Sang-We Kim, Min Hee Hong, Ji-Youn Han, Chan-Young Ock, Jong-Seok Lee, In Jae Oh, Shin Yup Lee, Cheol Hyeon Kim, Young Joo Min, Yoon Hee Choi, Jeong-Seon Ryu, Sun Hyo Park, Hee Kyung Ahn, Byoung-Yong Shim, Ki Hyeong Lee, Sung Yong Lee, Jin-Soo Kim, Jiun Yi, Su Kyung Choi, Hyonggin An, and Jin Hyoung Kang.
• Department of Hemato-Oncology, Konkuk Medical Center, University of Konkuk College of Medicine, Seoul, Republic of Korea.
• J. Cancer Res. Clin. Oncol. 2021 Aug 1; 147 (8): 2459-2469.

PurposeAlthough immune-checkpoint inhibitors have become a new therapeutic option for recurrent/metastatic non-small cell lung cancers (R/M-NSCLC), its clinical benefit in the real-world is still unclear.MethodsWe investigated 1181 Korean patients with programmed death-1 ligand 1 (PD-L1)-positive [tumor proportion score (TPS) ≥ 10% by the SP263 assay or ≥ 50% by the 22C3 assay] R/M-NSCLC treated with pembrolizumab or nivolumab after failure of platinum-based chemotherapy.ResultsThe median age was 67 years, 13% of patients had ECOG-PS ≥ 2, and 27% were never-smokers. Adenocarcinoma was predominant (61%) and 18.1% harbored an EGFR activating mutation or ALK rearrangement. Pembrolizumab and nivolumab were administered to 51.3% and 48.7, respectively, and 42% received them beyond the third-line chemotherapy. Objective response rate (ORR) was 28.6%. Pembrolizumab group showed numerically higher ORR (30.7%) than the nivolumab group (26.4%), but it was comparable with that of the nivolumab group having PD-L1 TPS ≥ 50% (32.4%). Median progression-free survival (PFS) and overall survival (OS) were 2.9 (95% CI 0-27.9) and 10.7 months (95% CI 0-28.2), respectively. In multivariable analysis, concordance of TPS ≥ 50% in both PD-L1 assays and the development of immune-related adverse events (irAEs) were two significant predictors of better ORR, PFS, and OS. EGFR mutation could also predict significantly worse OS outcomes.ConclusionThe real-world benefit of later-line anti-PD1 antibodies was comparable to clinical trials in patients with R/M-NSCLC, although patients generally were more heavily pretreated and had poorer ECOG-PS. Concordantly high PD-L1 TPS ≥ 50% and development of irAE could independently predict better treatment outcomes, while EGFR mutation negatively affected OS.

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