Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients
Authors: Yong Jiang
Haihua Luo
Mao Lin
Aihua Liu
Jibing Chen
Shuzhen Liang
Lizhi Niu
Journal: Journal of Clinical Investigation (2020)
Discipline: CLINICAL MEDICINE
Keywords: Cancer immunotherapy; Immunology; Lung cancer; Therapeutics.
Affiliations: Guangdong Provincial Key Laboratory of Proteomics, State Key Laboratory of Organ Failure Research, School of Basic Medical Sciences, Southern Medical University, Guangzhou, China., Biological Treatment Center, Fuda Cancer Hospital, Jinan University, Guangzhou, China., Medical Research Centre, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China., Department of Respiratory and Critical Care Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, China., Cancer Center, Fuda Cancer Hospital, Jinan University, Guangzhou, China.

Abstract:  BACKGROUNDThe anti-programmed cell death 1 (anti-PD-1) antibody pembrolizumab is clinically active against non-small cell lung cancer (NSCLC). In addition to T cells, human natural killer (NK) cells, reported to have the potential to prolong the survival of patients with advanced NSCLC, also express PD-1. This study aimed to investigate the safety and efficacy of pembrolizumab plus allogeneic NK cells in patients with previously treated advanced NSCLC.METHODSIn total, 109 enrolled patients with a programmed death ligand 1 (PD-L1) tumor proportion score (TPS) of 1% or higher were randomly allocated to group A (n = 55 patients given pembrolizumab plus NK cells) or group B (n = 54 patients given pembrolizumab alone). The patients received i.v. pembrolizumab (10 mg/kg) once every 3 weeks and continued treatment until the occurrence of tumor progression or unacceptable toxicity. The patients in group A continuously received 2 cycles of NK cell therapy as 1 course of treatment.RESULTSIn our study, patients in group A had longer survival than did patients in group B (median overall survival [OS]: 15.5 months vs. 13.3 months; median progression-free survival [PFS]: 6.5 months vs. 4.3 months; P &lt; 0.05). In group A patients with a TPS of 50% or higher, the median OS and PFS was significantly longer. Moreover, the patients in group A treated with multiple courses of NK cell infusion had better OS (18.5 months) than did those who received a single course of NK cell infusion (13.5 months).CONCLUSIONPembrolizumab plus NK cell therapy yielded improved survival benefits in patients with previously treated PD-L1+ advanced NSCLC.TRIAL REGISTRATIONClinicalTrials.gov NCT02843204.FUNDINGThis work was supported by grants from the National Natural Science Foundation of China (NSFC) - Guangdong Joint Foundation of China (no. U1601225); the NSFC (no. 81671965); the Guangdong Provincial Key Laboratory Construction Project of China (no. 2017B030314034); and the Key Scientific and Technological Program of Guangzhou City (no. 201607020016). 

Retracted: No

PubPeer comments:
 According to the trial registration information [NCT02843204](http: https: clinicaltrials.gov ct2 show NCT02843204), The trial used **Nivolumab** plus NK, but the trial title is **Anti-PD-L1**. More interestingly, this paper indictates Pembrolizumab plus NK. So IMO, the registered trial NCT02843204 is a not related to this paper. , 
 The trial registration information of NCT02843204 had been updated. Please check the updated information. ,