• NICT and PCT are current first-line therapies for advanced NSCLC. • This study compares the long-term efficacy and safety of NICT versus PCT. • NICT provided longer survival benefits in patients with PD-L1 TPS < 1% • Comparable survival outcomes were observed for both groups with PD-L1 TPS ≥ 1% • TRAEs were tolerable with comparable TRDs. NICT and PCT are current first-line therapies for advanced NSCLC. This study compares the long-term efficacy and safety of NICT versus PCT. NICT provided longer survival benefits in patients with PD-L1 TPS < 1% Comparable survival outcomes were observed for both groups with PD-L1 TPS ≥ 1% TRAEs were tolerable with comparable TRDs. Nivolumab plus ipilimumab with chemotherapy (NICT) and pembrolizumab with chemotherapy (PCT) are widely used first-line regimens for advanced non–small-cell lung cancer (NSCLC) lacking actionable driver mutations. However, real-world evidence comparing long-term survival outcomes between two regimens, particularly when stratified by PD-L1 tumor proportion score (TPS), remains limited. We retrospectively analyzed 457 patients treated with NICT or PCT across 13 institutions in Japan between January 2019 and December 2022. Patients were classified into PD-L1 TPS < 1% and ≥ 1% cohorts. Overall survival (OS) and treatment-related adverse events (TRAEs) were assessed using propensity score methods, including inverse probability treatment weighting (IPTW) and overlap weighting (OW), adjusting for 10 clinically relevant covariates. The duration of median follow-up exceeded 40 months. Among 161 patients with PD-L1 TPS < 1% (NICT n = 43; PCT n = 118), NICT achieved significantly longer OS than PCT (median 47.4 versus 16.6 months; IPTW-adjusted hazard ratio 0.50; p = 0.007), with superior 36-month OS rates (51.5% versus 28.2%; p = 0.016). These trends remained robust in the OW sensitivity analysis. In contrast, among 296 patients with PD-L1 TPS ≥ 1% (NICT n = 45; PCT n = 251), no significant differences were observed in median OS or 36-month OS rates between regimens. Grade ≥ 3 TRAEs, treatment discontinuation, and treatment-related death rates were comparable (p = 0.37, 0.78, and 0.32, respectively). NICT provides a sustained long-term survival advantage over PCT with comparable tolerability and may be a promising therapeutic option for the treatment of advanced NSCLC that are PD-L1 negative.
Kinehara et al. (Sun,) studied this question.
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