Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Anti-LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Sun Dongchen, Chen Gang, Chen Yu, Qu Song, Liu Lei, Yang Kunyu, Li Jingao, Chen Lisha, Huang Xiaoming, Zhu Haisheng, Tang Wenjun, Wang Rensheng, Han Yaqian, Hu Desheng, Gao Jin, Chen Xiaozhong, Xiong Hailin, Chen Wu, Fan Bin, Cai Shengli, Kang Xiaoqiang, Zhang Li, Yang Yunpeng
Аннотация
PURPOSE: Prior studies reported synergistic antitumor activity by dual inhibition of lymphocyte activation gene-3 (LAG-3) and PD-1. This study investigated the activity, safety, and biomarker of LAG-3/PD-1 co-blockade plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
PATIENTS AND METHODS: Previously untreated patients with RM-NPC received LBL-007 (anti-LAG-3), tislelizumab (anti-PD-1), and gemcitabine-cisplatin for four to six cycles, followed by maintenance therapy with LBL-007 and tislelizumab. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), duration of response (DoR), time to response, disease control rate (DCR), overall survival (OS), and safety. Biomarker analysis included LAG-3 and PD-L1 expression.
RESULTS: Forty-two patients were enrolled from 15 centers in China. With a median follow-up of 19.0 months, the ORR was 83.3% [95% confidence interval (CI), 68.6%-93.0%], and the DCR was 97.6% (95% CI, 87.4%-99.9%). The median PFS reached 15.8 months (95% CI, 9.9-not estimable); the 12-month PFS rate was 55.1% (95% CI, 41.7%-72.9%). The median DoR was 14.6 months (95% CI, 10.3-not estimable); the median OS was not reached. Grade 3 or higher treatment-related adverse events occurred in 37 patients (98.1%). No new safety signals were identified. In biomarker analysis, patients with dual-positive LAG-3/PD-L1 expression demonstrated more favorable outcomes than those lacking either biomarker, including a 12-month PFS rate of 65.0% versus 40.2% and median PFS of 16.0 versus 10.3 months.
CONCLUSIONS: LBL-007 plus tislelizumab and chemotherapy shows promising clinical benefits and manageable toxicity as first-line therapy for RM-NPC. Dual-positive LAG-3/PD-L1 expression was associated with improved outcomes, supporting further exploration of this biomarker-defined subpopulation in randomized trials.
PATIENTS AND METHODS: Previously untreated patients with RM-NPC received LBL-007 (anti-LAG-3), tislelizumab (anti-PD-1), and gemcitabine-cisplatin for four to six cycles, followed by maintenance therapy with LBL-007 and tislelizumab. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), duration of response (DoR), time to response, disease control rate (DCR), overall survival (OS), and safety. Biomarker analysis included LAG-3 and PD-L1 expression.
RESULTS: Forty-two patients were enrolled from 15 centers in China. With a median follow-up of 19.0 months, the ORR was 83.3% [95% confidence interval (CI), 68.6%-93.0%], and the DCR was 97.6% (95% CI, 87.4%-99.9%). The median PFS reached 15.8 months (95% CI, 9.9-not estimable); the 12-month PFS rate was 55.1% (95% CI, 41.7%-72.9%). The median DoR was 14.6 months (95% CI, 10.3-not estimable); the median OS was not reached. Grade 3 or higher treatment-related adverse events occurred in 37 patients (98.1%). No new safety signals were identified. In biomarker analysis, patients with dual-positive LAG-3/PD-L1 expression demonstrated more favorable outcomes than those lacking either biomarker, including a 12-month PFS rate of 65.0% versus 40.2% and median PFS of 16.0 versus 10.3 months.
CONCLUSIONS: LBL-007 plus tislelizumab and chemotherapy shows promising clinical benefits and manageable toxicity as first-line therapy for RM-NPC. Dual-positive LAG-3/PD-L1 expression was associated with improved outcomes, supporting further exploration of this biomarker-defined subpopulation in randomized trials.