- Lung and Thoracic cancer
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A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer
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Eo Jin Kim, Yong-Hee Cho, Dong Ha Kim, Dae-Hyun Ko, Eun-Ju Do, Sang-Yeob Kim, Yong Man Kim, Jae Seob Jung, Yoonmi Kang, Wonjun Ji, Myeong Geun Choi, Jae Cheol Lee, Jin Kyung Rho, Chang-Min Choi
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Cancer Res Treat. 2022;54(4):1005-1016. Published online December 3, 2021
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DOI: https://doi.org/10.4143/crt.2021.986
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 Abstract
 PDF Supplementary Material PubReader ePub
- 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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Citations
Citations to this article as recorded by  - Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical st
Myeong Geun Choi, Gun Woo Son, Mi Young Choi, Jae Seob Jung, Jin Kyung Rho, Wonjun Ji, Byeong Gon Yoon, Jong-Min Jo, Yong Man Kim, Dae-Hyun Ko, Jae Cheol Lee, Chang-Min Choi
Journal for ImmunoTherapy of Cancer.2024; 12(3): e008585. CrossRef - Disruption of TGF-β signaling pathway is required to mediate effective killing of hepatocellular carcinoma by human iPSC-derived NK cells
Jaya Lakshmi Thangaraj, Michael Coffey, Edith Lopez, Dan S. Kaufman
Cell Stem Cell.2024; 31(9): 1327. CrossRef - Strategies to enhance the therapeutic efficacy of anti-PD-1 antibody, anti-PD-L1 antibody and anti-CTLA-4 antibody in cancer therapy
Xin Su, Jian Li, Xiao Xu, Youbao Ye, Cailiu Wang, Guanglong Pang, Wenxiu Liu, Ang Liu, Changchun Zhao, Xiangyong Hao
Journal of Translational Medicine.2024;[Epub] CrossRef - Epigenetic regulation of NKG2D ligand and the rise of NK cell-based immunotherapy for cancer treatment
Raj Kumar, Romi Gupta
Frontiers in Oncology.2024;[Epub] CrossRef - Efficacy and safety of natural killer cell therapy in patients with solid tumors: a systematic review and meta-analysis
Heesook Park, Gyurin Kim, Najin Kim, Sungyoen Ha, Hyeonwoo Yim
Frontiers in Immunology.2024;[Epub] CrossRef - Cellular Therapy in NSCLC: Between Myth and Reality
Martina Imbimbo, Laureline Wetterwald, Alex Friedlaender, Kaushal Parikh, Alfredo Addeo
Current Oncology Reports.2023; 25(10): 1161. CrossRef - NK cell activity and methylated HOXA9 ctDNA as prognostic biomarkers in patients with non-small cell lung cancer treated with PD-1/PD-L1 inhibitors
Sara Witting Christensen Wen, Line Nederby, Rikke Fredslund Andersen, Torben Schjødt Hansen, Christa Haugaard Nyhus, Ole Hilberg, Anders Jakobsen, Torben Frøstrup Hansen
British Journal of Cancer.2023; 129(1): 135. CrossRef - Harnessing Natural Killer Cells for Lung Cancer Therapy
Shoubao Ma, Michael A. Caligiuri, Jianhua Yu
Cancer Research.2023; 83(20): 3327. CrossRef - Natural killer cells: the next wave in cancer immunotherapy
Xin Chen, Lei Jiang, Xuesong Liu
Frontiers in Immunology.2022;[Epub] CrossRef
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