A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Canceropen access
- Authors
- Kim, E.J.[Kim, E.J.]; Cho, Y.-H.[Cho, Y.-H.]; Kim, D.H.[Kim, D.H.]; Ko, D.-H.[Ko, D.-H.]; Do, E.-J.[Do, E.-J.]; Kim, S.-Y.[Kim, S.-Y.]; Kim, Y.M.[Kim, Y.M.]; Jung, J.S.[Jung, J.S.]; Kang, Y.[Kang, Y.]; Ji, W.[Ji, W.]; Choi, M.G.[Choi, M.G.]; Lee, J.C.[Lee, J.C.]; Rho, J.K.[Rho, J.K.]; Choi, C.-M.[Choi, C.-M.]
- Issue Date
- Oct-2022
- Publisher
- Korean Cancer Association
- Keywords
- Combination therapy; NK cell; Non-small cell lung carcinoma; Pembrolizumab
- Citation
- Cancer Research and Treatment, v.54, no.4, pp.1005 - 1016
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Cancer Research and Treatment
- Volume
- 54
- Number
- 4
- Start Page
- 1005
- End Page
- 1016
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/101368
- DOI
- 10.4143/crt.2021.986
- ISSN
- 1598-2998
- 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. © 2022 by the Korean Cancer Association.
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