Long-Term Nationwide Post-Marketing Surveillance Cohort Study of Nivolumab in Advanced Non-Small-Cell Lung Cancer

Background Clinical trials of immune-checkpoint inhibitors (ICIs) have shown a characteristic long-term survival plateau in non-small-cell lung cancer (NSCLC), yet long-term real-world Asian data on nivolumab are limited. We analyzed a consecutively enrolled post-marketing surveillance (PMS) cohort of Japanese patients treated with nivolumab to evaluate long-term overall survival (OS). Methods All patients who started nivolumab monotherapy for previously treated NSCLC between December 2015 and February 2017 and were registered in the nationwide PMS programme were eligible. Survival status was updated through December 2023. OS was estimated with the Kaplan–Meier method, and annual survival rates and 95 % confidence intervals (CIs) were calculated. Individual patient data for the CheckMate 017/057 trials were reconstructed from published Kaplan-Meier curves and compared with the PMS cohort to assess concordance. Results Of 834 registered patients, 832 were evaluable for OS. With a median follow-up of 80.6 months, median OS was 10.23 months (95 % CI 9.11–11.51). Yearly OS rates were 44.9 % (1 year), 26.1 % (2 years), 16.9 % (3 years), 12.8 % (4 years), 9.4 % (5 years), 7.8 % (6 years) and 6.6 % (7 years), demonstrating a sustained tail effect on the Kaplan–Meier curve. ECOG performance status 0–1, earlier treatment line and lower clinical stage were associated with superior survival. OS in the PMS and reconstructed CheckMate cohorts was nearly identical (hazard ratio [HR] 1.01; 95 % CI 0.89–1.14; p = 0.933). In a subgroup matching CheckMate eligibility criteria (ECOG 0–1, second-line, stage IIIB/IV), the PMS cohort showed longer OS (HR 0.78; 95 % CI 0.63–0.97; p = 0.023). Conclusions This study provides one of the longest Asian real-world cohorts with at least seven years of follow-up and supports the presence of durable long-term survival after nivolumab treatment in routine clinical practice.