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Cancer Research and Treatment > Epub ahead of print
doi: https://doi.org/10.4143/crt.2021.986    [Epub ahead of print]
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
Eo Jin Kim1,2 , Yong-Hee Cho3,4 , Dong Ha Kim3, Dae-Hyun Ko5, Eun-Ju Do3, Sang-Yeob Kim6, Yong Man Kim7, Jae Seob Jung7, Yoonmi Kang7, Wonjun Ji8, Myeong Geun Choi8, Jae Cheol Lee1, Jin Kyung Rho6 , Chang-Min Choi1,8
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
3Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4Data Convergence Drug Research Center, Therapeutics and Biotechnology Division, Korea Research Institute of Chemical Technology (KRICT), Daejeon, Korea
5Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
6Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
7NKMAX Co., Ltd., Seongnam, Korea
8Department of Pulmonology and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence  Jin Kyung Rho ,Tel: 82-2-3010-2974, Fax: 82-2-3010-6961, Email: jkrho@amc.seoul.kr
Chang-Min Choi ,Tel: 82-2-3010-5902, Fax: 82-2-3010-6961, Email: ccm@amc.seoul.kr
Received: September 3, 2021;  Accepted: November 29, 2021.  Published online: December 3, 2021.
*Eo Jin Kim and Yong-Hee Cho contributed equally to this work.
ABSTRACT
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.
Key words: Non-small cell lung carcinoma, NK cell, Pembrolizumab, Combination therapy
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