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

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 showed long-term, durable clinical benefit in Japanese patients with metastatic NSCLC and tumor PD-L1 < 1%, suggesting potential clinical benefit with its use as a first-line treatment for this hard-to-treat population.