Nivolumab plus ipilimumab-based treatment in Japanese patients with metastatic non-small cell lung cancer and tumor PD-L1 < 1%: a pooled analysis

作者：Nishio M, Hayashi H, Goto Y, Ikeda S, Yokoyama T, Tanaka H, Tambo Y, Hotta K, Fukuhara T, Daga H, Masubuchi K, Aoyama T, Tschaika M, Hu N, Mizutani H · 发表于：International journal of clinical oncology · 年份：2026 · DOI：10.1007/s10147-026-03116-w

BACKGROUND: Nivolumab plus ipilimumab-based therapies have shown long-term, durable clinical benefit in patients with metastatic non-small cell lung cancer (NSCLC), including those with tumor programmed death-ligand 1 (PD-L1) expression < 1%, a population with high unmet need. Here we report long-term clinical outcomes with first-line nivolumab plus ipilimumab with or without chemotherapy (2 cycles) versus chemotherapy (≤ 4 cycles) in a pooled population of Japanese patients with metastatic NSCLC and tumor PD-L1 < 1% from the randomized, phase 3 CheckMate 227 (NCT02477826) and CheckMate 9LA (NCT03215706) studies. METHODS: Adults with stage IV/recurrent NSCLC without sensitizing EGFR/ALK alterations were included. Overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety were assessed. RESULTS: Among the pooled population of Japanese patients with tumor PD-L1 < 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 34) versus chemotherapy (n = 41) arms, median OS was 41.0 (95% CI 19.4-not reached) versus 15.2 (95% CI 7.6-21.3) months (hazard ratio [HR] 0.46; 95% CI 0.27-0.78); 5-year OS rates were 38% (95% CI 22-54) versus 16% (95% CI 6-30). Median PFS was 8.2 (95% CI 4.1-19.3) versus 5.6 (95% CI 4.2-7.0) months (HR 0.57 [95% CI 0.31-1.03]). No new safety signals were observed. CONCLUSIONS: Consistent with results in the pooled global population, nivolumab plus ipilimumab with or without chemotherapy sho...