Department of Pulmonology and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Information Medicine, Asan medical center, Seoul, South Korea.
Thorac Cancer. 2022 Jul;13(14):2050-2056. doi: 10.1111/1759-7714.14523. Epub 2022 Jun 6.
A previous trial showed that autologous ex-vivo expanded NK cell (SNK01) treatment combined with pembrolizumab showed better efficacy than pembrolizumab monotherapy in advanced non-small cell lung cancer (NSCLC). This study was a 2-year follow-up of that previous study to determine the long-term efficacy of the combination treatment.
This trial included 20 patients with advanced NSCLC with a PD-L1 tumor proportion score of 1% or greater who failed prior to front-line platinum-based therapy. The patients received pembrolizumab with low-dose SNK01 (2 × 10 cells/dose) or high-dose SNK01 (4 × 10 cells/dose), or pembrolizumab monotherapy. The primary study endpoint was overall survival (OS), and the secondary endpoint was progression-free survival (PFS).
Two patients were excluded following serious adverse events. Among the 11 patients who died, five were from the NK groups (41.6%, n = 5/12), and six received pembrolizumab monotherapy (100%, n = 6/6). The estimated 2-year survival rate was 58.3% versus 16.7% (pembrolizumab plus SNK01 vs. pembrolizumab monotherapy). The hazard ratio of pembrolizumab plus SNK01 compared with pembrolizumab monotherapy was 0.32 (95% CI: 0.1, 1.08, p-value: 0.066). Although the median PFS was significantly higher in the pembrolizumab plus SNK01 group than in the pembrolizumab alone group, OS and PFS did not differ statistically between patients who received low doses of NK cells and those who received high doses of NK cells.
Autologous NK cells can enhance the long-term OS and PFS for NSCLC. A larger study is needed to confirm this result. Clinical Research Information Service number: KCT0003463.
先前的一项试验表明，自体体外扩增的自然杀伤细胞（SNK01）联合帕博利珠单抗治疗晚期非小细胞肺癌（NSCLC）的疗效优于帕博利珠单抗单药治疗。本研究是对先前研究的 2 年随访，旨在确定联合治疗的长期疗效。
该试验纳入了 20 例 PD-L1 肿瘤比例评分≥1%的晚期 NSCLC 患者，这些患者在一线铂类治疗前已失败。患者接受帕博利珠单抗联合低剂量 SNK01（2×10 个细胞/剂量）或高剂量 SNK01（4×10 个细胞/剂量）或帕博利珠单抗单药治疗。主要研究终点为总生存期（OS），次要终点为无进展生存期（PFS）。
2 例患者因严重不良事件被排除。在 11 例死亡患者中，NK 组 5 例（41.6%，n=5/12），帕博利珠单抗单药组 6 例（100%，n=6/6）。估计 2 年生存率为 58.3%与 16.7%（帕博利珠单抗联合 SNK01 与帕博利珠单抗单药治疗）。与帕博利珠单抗单药治疗相比，帕博利珠单抗联合 SNK01 的风险比为 0.32（95%CI：0.1，1.08，p 值：0.066）。虽然帕博利珠单抗联合 SNK01 组的中位 PFS 明显高于帕博利珠单抗单药组，但接受低剂量 NK 细胞和高剂量 NK 细胞的患者的 OS 和 PFS 无统计学差异。
自体 NK 细胞可提高 NSCLC 的长期 OS 和 PFS。需要更大规模的研究来证实这一结果。临床研究信息服务编号：KCT0003463。
