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
| Autor: | Sang-Yeob Kim, Yong Man Kim, Dong Ha Kim, Yoonmi Kang, Jae Seob Jung, Jin Kyung Rho, Eo Jin Kim, Eun-Ju Do, Wonjun Ji, Myeong Geun Choi, Dae-Hyun Ko, Chang-Min Choi, Yong-Hee Cho, Jae Cheol Lee |
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| Rok vydání: | 2022 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Lung Neoplasms Combination therapy business.industry Pembrolizumab Antibodies Monoclonal Humanized B7-H1 Antigen law.invention Clinical trial Randomized controlled trial law Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols Toxicity Quality of Life medicine Clinical endpoint Humans business Adverse effect Survival rate |
| Zdroj: | Cancer Research and Treatment. 54:1005-1016 |
| ISSN: | 2005-9256 1598-2998 |
| DOI: | 10.4143/crt.2021.986 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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