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Introduction <p>RATIONALE-304 compared first-line tislelizumab (a programmed cell death protein&#xa0;1 inhibitor) plus chemotherapy versus chemotherapy in advanced non-squamous non-small cell lung cancer (nsq-NSCLC). This exploratory analysis focused on patients with tumor cell&#xa0;programmed death ligand&#xa0;1 (PD-L1) expression ≥ 50%.</p> Methods <p>Patients with stage&#xa0;IIIB/IV nsq-NSCLC were randomized (2:1) to tislelizumab plus platinum-based chemotherapy and pemetrexed every 3&#xa0;weeks, followed by maintenance tislelizumab and pemetrexed, or platinum-based chemotherapy and pemetrexed followed by maintenance pemetrexed. The primary endpoint was independent review committee (IRC)-assessed progression-free survival (PFS); secondary endpoints included overall survival (OS), IRC-assessed objective response rates, and safety.</p> Results <p>The PD-L1 ≥ 50% population included 110 patients (tislelizumab plus chemotherapy, <i>n</i> = 74; chemotherapy, <i>n</i> = 36); 71.8% (<i>n</i> = 79) were male and 28.2% (<i>n</i> = 31) were female. Consistent with the final analysis (median follow-up 16.5&#xa0;months), the 4-year follow-up data (median follow-up 23.4&#xa0;months) continued to show an improvement in median PFS (17.2 vs. 4.6&#xa0;months; stratified HR 0.29, 95%&#xa0;CI 0.17–0.50) and median OS (41.9 vs. 13.1&#xa0;months; stratified HR 0.38, 95%&#xa0;CI 0.23–0.62) for patients who received tislelizumab plus chemotherapy versus chemotherapy. An additional post&#xa0;hoc analysis showed no significant differences in PFS or OS between PD-L1 50–89% and ≥ 90% subgroups in the tislelizumab plus chemotherapy arm. The safety profile of tislelizumab plus chemotherapy was manageable and consistent with previous analyses.</p> Conclusions <p>In patients with advanced nsq-NSCLC and PD-L1 tumor cell&#xa0;expression ≥ 50%, first-line tislelizumab plus chemotherapy demonstrated clinically meaningful improvement in PFS and OS versus chemotherapy. Efficacy was consistent across subgroups of patients with high PD-L1 tumor cell&#xa0;expression levels (50–89% and ≥ 90%).</p> Trial registration <p>Clinical Trials.gov NCT03663205.</p>

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First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 ≥ 50% Subgroup Analysis from the RATIONALE-304 Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月14日

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  • Shun Lu,
  • Jie Wang,
  • Yan Yu,
  • Xinmin Yu,
  • Yanping Hu,
  • Liao Wangjun,
  • Xingya Li,
  • Yuepeng Liu,
  • Weidong Li,
  • Xiaofei Qu,
  • Yuanyuan Bao,
  • Mengzhao Wang

摘要

Introduction

RATIONALE-304 compared first-line tislelizumab (a programmed cell death protein 1 inhibitor) plus chemotherapy versus chemotherapy in advanced non-squamous non-small cell lung cancer (nsq-NSCLC). This exploratory analysis focused on patients with tumor cell programmed death ligand 1 (PD-L1) expression ≥ 50%.

Methods

Patients with stage IIIB/IV nsq-NSCLC were randomized (2:1) to tislelizumab plus platinum-based chemotherapy and pemetrexed every 3 weeks, followed by maintenance tislelizumab and pemetrexed, or platinum-based chemotherapy and pemetrexed followed by maintenance pemetrexed. The primary endpoint was independent review committee (IRC)-assessed progression-free survival (PFS); secondary endpoints included overall survival (OS), IRC-assessed objective response rates, and safety.

Results

The PD-L1 ≥ 50% population included 110 patients (tislelizumab plus chemotherapy, n = 74; chemotherapy, n = 36); 71.8% (n = 79) were male and 28.2% (n = 31) were female. Consistent with the final analysis (median follow-up 16.5 months), the 4-year follow-up data (median follow-up 23.4 months) continued to show an improvement in median PFS (17.2 vs. 4.6 months; stratified HR 0.29, 95% CI 0.17–0.50) and median OS (41.9 vs. 13.1 months; stratified HR 0.38, 95% CI 0.23–0.62) for patients who received tislelizumab plus chemotherapy versus chemotherapy. An additional post hoc analysis showed no significant differences in PFS or OS between PD-L1 50–89% and ≥ 90% subgroups in the tislelizumab plus chemotherapy arm. The safety profile of tislelizumab plus chemotherapy was manageable and consistent with previous analyses.

Conclusions

In patients with advanced nsq-NSCLC and PD-L1 tumor cell expression ≥ 50%, first-line tislelizumab plus chemotherapy demonstrated clinically meaningful improvement in PFS and OS versus chemotherapy. Efficacy was consistent across subgroups of patients with high PD-L1 tumor cell expression levels (50–89% and ≥ 90%).

Trial registration

Clinical Trials.gov NCT03663205.