Multicenter phase 2 trial of first-line LBL-007 plus tislelizumab and chemotherapy for advanced nasopharyngeal carcinoma

A phase 3 trial at 15 centers in China evaluated the combination of LBL-007 (anti-LAG-3) and tislelizumab (anti-PD-1) and gemcitabine-cisplatin chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). Patients received the combination for 4 to 6 cycles, followed by LBL-007 and tislelizumab maintenance therapy. The median duration of follow-up was 19.0 months. Primary endpoint was objective response rate. Among 42 patients, ORR was 83.3% (95% CI 68.6-93.0) and disease control rate was 97.6% (87.4-99.9), median progression-free survival was 15.8 months (9.9-NE) with a 12-month PFS rate of 55.1% (41.7-72.9), median duration of response was 14.6 months (10.3-NE), and median overall survival was not reached. Grade 3 or higher treatment-related adverse events occurred in 37 patients (98.1%), with no new safety signals identified. In biomarker analysis, patients with dual positive LAG-3/PD-L1 expression had more favorable outcomes than those lacking either biomarker, including 12-month PFS rate of 65% versus 40.2% and median PFS of 16.0 versus 10.3 months. The authors conclude that LBL-007 plus tislelizumab and chemotherapy showed promising clinical benefit and manageable toxicity as first-line therapy for RM-NPC.