Clinical Outcomes of First-Line Pembrolizumab Monotherapy in Advanced NSCLC With PD-L1 Tumor Proportion Score of 1% to 49%: A Retrospective Multicenter Study

IF 3.6 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2026-04-01 Epub Date: 2026-01-05 DOI:10.1016/j.jtocrr.2026.100953

Akito Miyazaki MD , Kinnosuke Matsumoto MD , Motohiro Tamiya MD , Kiyohide Komuta MD , Kensuke Kanaoka MD , Tomoki Kuge MD , Takayuki Shiroyama MD, PhD , Akihiro Tsukaguchi MD , Akihiro Tamiya MD , Keijiro Yamauchi MD, PhD , Hidekazu Suzuki MD , Yasuhiro Mihashi MD , Masahide Mori MD, PhD , Koki Moritomo MD , Yuhei Kinehara MD, PhD , Midori Yoneda MD , Osamu Morimura MD, PhD , Kouji Azuma MD , Satoshi Tanaka MD , Toshie Niki MD, PhD , Atsushi Kumanogoh MD, PhD

{"title":"Clinical Outcomes of First-Line Pembrolizumab Monotherapy in Advanced NSCLC With PD-L1 Tumor Proportion Score of 1% to 49%: A Retrospective Multicenter Study","authors":"Akito Miyazaki MD , Kinnosuke Matsumoto MD , Motohiro Tamiya MD , Kiyohide Komuta MD , Kensuke Kanaoka MD , Tomoki Kuge MD , Takayuki Shiroyama MD, PhD , Akihiro Tsukaguchi MD , Akihiro Tamiya MD , Keijiro Yamauchi MD, PhD , Hidekazu Suzuki MD , Yasuhiro Mihashi MD , Masahide Mori MD, PhD , Koki Moritomo MD , Yuhei Kinehara MD, PhD , Midori Yoneda MD , Osamu Morimura MD, PhD , Kouji Azuma MD , Satoshi Tanaka MD , Toshie Niki MD, PhD , Atsushi Kumanogoh MD, PhD","doi":"10.1016/j.jtocrr.2026.100953","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>This study aimed to evaluate the real-world clinical outcomes of pembrolizumab monotherapy in patients with advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% to 49%.</div></div><div><h3>Methods</h3><div>A multicenter retrospective analysis was conducted for outcomes of 114 patients with stages II to IV or recurrent NSCLC and PD-L1 TPS of 1% to 49%, who received first-line pembrolizumab monotherapy.</div></div><div><h3>Results</h3><div>The median progression-free survival (PFS) was 5.6 months, with 6-month and 60-month PFS rates of 47.4% and 5.1%, respectively. The median overall survival (OS) was 15.8 months, with 24-month and 60-month OS rates of 34.8% and 17.0%, respectively. The objective response rate was 36.9%, and the disease control rate was 60.4%. Multivariate analysis identified liver metastasis as a significant negative prognostic factor for PFS, but a high neutrophil-to-lymphocyte ratio (NLR) revealed a trend toward worse PFS. Similarly, liver metastasis, high NLR, and poor performance status were significantly associated with worse OS. Grade more than or equal to 3 immune-related adverse events were observed in 20.2% of patients, with pneumonitis being the most common. Those with a history of interstitial lung disease had a higher incidence of severe pneumonitis than those without. Treatment discontinuation due to disease progression occurred in 65.8% of patients, whereas 23.7% discontinued due to adverse events.</div></div><div><h3>Conclusions</h3><div>First-line pembrolizumab monotherapy demonstrated moderate efficacy and acceptable safety in patients with advanced NSCLC with PD-L1 TPS of 1% to 49%. Liver metastasis, high NLR, and poor performance status were identified as prognostic factors.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"7 4","pages":"Article 100953"},"PeriodicalIF":3.6000,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JTO Clinical and Research Reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666364326000044","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/5 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction

This study aimed to evaluate the real-world clinical outcomes of pembrolizumab monotherapy in patients with advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1% to 49%.

Methods

A multicenter retrospective analysis was conducted for outcomes of 114 patients with stages II to IV or recurrent NSCLC and PD-L1 TPS of 1% to 49%, who received first-line pembrolizumab monotherapy.

Results

The median progression-free survival (PFS) was 5.6 months, with 6-month and 60-month PFS rates of 47.4% and 5.1%, respectively. The median overall survival (OS) was 15.8 months, with 24-month and 60-month OS rates of 34.8% and 17.0%, respectively. The objective response rate was 36.9%, and the disease control rate was 60.4%. Multivariate analysis identified liver metastasis as a significant negative prognostic factor for PFS, but a high neutrophil-to-lymphocyte ratio (NLR) revealed a trend toward worse PFS. Similarly, liver metastasis, high NLR, and poor performance status were significantly associated with worse OS. Grade more than or equal to 3 immune-related adverse events were observed in 20.2% of patients, with pneumonitis being the most common. Those with a history of interstitial lung disease had a higher incidence of severe pneumonitis than those without. Treatment discontinuation due to disease progression occurred in 65.8% of patients, whereas 23.7% discontinued due to adverse events.

Conclusions

First-line pembrolizumab monotherapy demonstrated moderate efficacy and acceptable safety in patients with advanced NSCLC with PD-L1 TPS of 1% to 49%. Liver metastasis, high NLR, and poor performance status were identified as prognostic factors.

查看原文本刊更多论文

一线派姆单抗单药治疗PD-L1肿瘤比例评分为1%至49%的晚期NSCLC的临床结果：一项回顾性多中心研究

本研究旨在评估派姆单抗单药治疗程序性死亡-配体1 （PD-L1）肿瘤比例评分（TPS）为1%至49%的晚期NSCLC患者的实际临床结果。方法对114例接受一线派姆单抗单药治疗的II ~ IV期或复发性非小细胞肺癌、PD-L1 TPS为1% ~ 49%的患者进行多中心回顾性分析。结果中位无进展生存期（PFS）为5.6个月，6个月和60个月PFS率分别为47.4%和5.1%。中位总生存期（OS）为15.8个月，24个月和60个月的OS率分别为34.8%和17.0%。客观有效率为36.9%，疾病控制率为60.4%。多因素分析发现肝转移是PFS的一个重要的负面预后因素，但高中性粒细胞与淋巴细胞比率（NLR）显示PFS恶化的趋势。同样，肝转移、高NLR和较差的工作状态与较差的OS显著相关。20.2%的患者出现大于或等于3级的免疫相关不良事件，其中肺炎最为常见。有间质性肺疾病史的患者发生严重肺炎的几率高于无间质性肺疾病史的患者。65.8%的患者因疾病进展而停止治疗，而23.7%的患者因不良事件而停止治疗。结论在PD-L1 TPS为1% - 49%的晚期NSCLC患者中，一线派姆单抗单药治疗显示出中等疗效和可接受的安全性。肝转移、高NLR和运动状态不佳被认为是预后因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊