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논문 기본 정보

자료유형
학술저널
저자정보
김어진 (서울아산병원) 조용희 (한국화학연구원) 김동하 (서울아산병원) 고대현 (서울아산병원) 도은주 (서울아산병원) 김상엽 (서울아산병원) 김용만 (NKMAX Co. Ltd. Seongnam) 정재섭 (NKMAX Co. Ltd. Seongnam) 강윤미 (NKMAX Co. Ltd. Seongnam) 지원준 (서울아산병원) 최명근 (서울아산병원) 이재철 (울산대학교) 노진경 (울산대학교) 최창민 (울산대학교)
저널정보
대한암학회 Cancer Research and Treatment Cancer Research and Treatment 제54권 제4호
발행연도
2022.10
수록면
1,005 - 1,016 (12page)
DOI
10.4143/crt.2021.986

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Purpose The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial. Materials and Methods Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×109 or 4×109 cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life. Results Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×109 cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001). Conclusion Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

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