A Preliminary Analysis Of The Safety And Efficacy Of Neoantigens Combined With MASCT In The Treatment Of Advanced Lung Cancer

Objective: Multiple Antigen Specifc Cellular Therapy(MASCT)using neoantigens in vitro for the clinical treatment of non-small cell lung cancer(NSCLC)can increase the body’s immune killing and enhance the therapeutic effect.A prospective phase I/IIa trial was designed to evaluate the safety and efficacy of tumor neoantigens-added MASCT(Neo-MASCT)in patients with advanced NSCLC by objectively analyzing all clinical data.Methods: People with NSCLC in late disease stage had been screened into the group.They were treated with Neo-MASCT(n = 17)loaded with their own tumor neoantigens after the failure of existing standard therapies.Safety was the primary endpoint of the clinical trial,and the secondary endpoints were objective response rate(ORR)、progression-free survival(PFS)and overall survival(OS).Results: Results showed that the incidence of adverse reactions in patients receiving Neo-MASCT treatment was 58.8%(10/17).According to the CTCAE(version 4.03)rating standard,all treatment-related adverse reactions occurred at level 1/2,and no serious adverse reactions above grade 3 were observed in the study.The ORR of patients treated with Neo-MASCT was 41.2%,with a median PFS of 9.7 months and a median OS of 12.9 months,which was comparable to or better than some of the other similar studies.And compared with less than 3 cycles of the Neo-MASCT treatment of patients,more than 3 cycles of treatment of patients with a median PFS(12.3 and 6.9 months,respectively,P﹤0.05)and the median OS(14.6 and 9.9months,respectively,P﹤0.05)were significantly prolonged;PFS and OS of patients with more than 6 cycles of treatment improved more significantly than those with less than 6 cycles(median PFS 15.3 and 8.1 months,P﹤0.05;Median OS 16.5 and11.6 months,P﹤0.05).Multivariate analysis showed that more than 3 cycles of Neo-MASCT treatment was a good prognostic factor for improving patients’ PFS and OS,and increasing the number of cycles of Neo-MASCT treatment was more beneficial to patients’ survival.ELISPOT detection showed that the significant response to neoantigen,and positive changes as the treatment cycles increasing.Conclusion: In this study,no serious AEs were observed in patients with advanced NSCLC,and the survival time of patients was prolonged after the treatment by multiple cycles(at least 3 cycles).That may contribute new strategies for such patients.