Comparison of Long-Term Survival Between Nivolumab Plus Ipilimumab and Nivolumab Plus Ipilimumab With Chemotherapy in Advanced NSCLC: A Multicenter Retrospective Cohort Study

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Introduction Pivotal clinical trials have demonstrated the survival benefits of both nivolumab plus ipilimumab (NI) and nivolumab plus ipilimumab with two cycles of platinum-based chemotherapy (NICT) compared with chemotherapy. However, real-world evidence comparing NI and NICT with long-term follow-up remains limited. Methods We retrospectively analyzed 181 patients treated with NICT or NI across 13 institutions in Japan. The primary endpoints were median overall survival (OS) and the 36-month OS rate. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs). To reduce treatment-selection bias, 1:1 propensity score matching (PSM) was performed using 11 covariates. Results In the post-PSM cohort (47 pairs; n=94; median follow-up, 42.6 and 44.1 months), median PFS was 8.7 months with NICT versus 4.7 months with NI (hazard ratio [HR] 0.86; P=0.51). Median OS was 19.5 months with NICT versus 16.3 months with NI (HR 0.79; P=0.37), with similar 36-month OS rates (34.3% vs. 30.9%). ORR was significantly higher with NICT than with NI (68.1% vs 34.0%, P=0.002), as was DCR (83.0% vs 53.2%, P=0.004). NICT was associated with a higher cumulative incidence of TRAEs ≥ grade 3 (HR 2.25; 95% CI 1.03–4.91; Gray's test P=0.039). Treatment discontinuation and treatment-related deaths were comparable between groups. Conclusions With more than 40 months of follow-up, NICT was associated with higher response rates and incidence of TRAEs ≥ grade 3 than NI, without a clear PFS or OS advantage. Adding two-cycle chemotherapy may enhance early disease control but at the cost of increased toxicity, and this balance should be considered when selecting treatment for patients in whom tolerability is a major concern.

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