Sintilimab plus chemotherapy for first-line treatment of advanced pulmonary lymphoepithelioma-like carcinoma: Phase 2 trial

作者：Xinqing Lin, Haiyi Deng, Nianxin Fang, Likun Chen, Rui Chen, Xiaohong Xie, Zhanhong Xie, Jiexia Zhang, Ming Liu, Laiyu Liu, Ni Sun, Fei Wang, Yilin Yang, Xinze Lv, Zhou Zhang, Shangli Cai, Ting Hou, Shiyue Li, Jianxing He, Chengzhi Zhou · 发表于：Cell Reports Medicine · 年份：2025 · DOI：10.1016/j.xcrm.2025.102398 · 被引用次数：4 · 研究领域：Viral-associated cancers and disorders、Polyomavirus and related diseases、Lung Cancer Research Studies

Pulmonary lymphoepithelioma-like carcinoma (PLELC) is a unique non-small cell lung cancer associated with Epstein-Barr virus (EBV), lacking a standard treatment. This phase 2 study evaluates sintilimab plus gemcitabine and carboplatin (4 cycles), followed by sintilimab maintenance in 30 untreated patients with locally advanced or metastatic PLELC. At a median follow-up of 42.4 months, the objective response rate is 73.3% and disease control is 100.0%. The median progression-free survival (PFS) is 13.5 months (95% confidence interval [CI], 12.2–24.5), and median overall survival is 46.9 months (95% CI, 29.5-not reached [NR]). Grade ≥3 treatment-related adverse events occurred in 70.0% of patients, mainly neutropenia (46.7%). Higher T cell-inflamed gene-expression profile score is associated with longer PFS ( p = 0.003). Plasma EBV-DNA levels decrease with treatment response and increase with disease progression. Sintilimab plus chemotherapy shows promising efficacy with manageable safety as first-line treatment for advanced PLELC. This study was registered at ClinicalTrials.gov ( NCT04312204 ). • Multicenter, phase 2 trial of pulmonary lymphoepithelioma-like carcinoma • Sintilimab plus chemotherapy improves the median OS and PFS of patients with PLELC • Sintilimab plus chemotherapy is well tolerated with a favorable safety profile • GEP score and EBV-DNA concentration may be predictive biomarkers for the efficacy Lin et al. reveal that a prospective trial evaluating treatment ...