Long-term Outcomes of Neoadjuvant Nivolumab Plus Chemotherapy in Resectable NSCLC in Japanese Patients: Final 5-Year Follow-Up Analysis from CheckMate 816

Background Neoadjuvant nivolumab plus chemotherapy improved event-free survival (EFS) and pathological complete response (pCR) in Japanese patients with non-small cell lung cancer (NSCLC) compared with chemotherapy alone in the CheckMate 816 study (NCT02998528). Overall survival (OS) and updated EFS data from the Japanese subpopulation in this study are needed. Methods The phase 3 open-label study randomized patients with stage IB–IIIA resectable NSCLC to receive three cycles of nivolumab plus chemotherapy or chemotherapy alone before undergoing definitive surgery. Primary endpoints were EFS and pCR. OS and safety were secondary and exploratory endpoints, respectively. Results Sixty-eight Japanese patients were concurrently assigned to receive nivolumab plus chemotherapy (n = 33) or chemotherapy alone (n = 35). Baseline characteristics were generally balanced between treatment arms. In this final analysis, 75.0% of patients in the nivolumab-plus-chemotherapy arm were still alive, and 43.3% were alive without disease progression or recurrence, compared with 64.7% and 37.4%, respectively, in the chemotherapy-alone arm. Median OS at 5 years was not reached in patients treated with nivolumab plus chemotherapy and 76.8 months in patients treated with chemotherapy alone. Most subgroup analyses of OS showed similar results to the overall Japanese subpopulation. At final data cutoff, eight patients in the nivolumab-plus-chemotherapy arm had died due to lung cancer, compared with 12 patients in the chemotherapy-alone arm. No new safety signals were identified. Conclusion Neoadjuvant nivolumab plus chemotherapy prolonged OS compared with chemotherapy alone in the Japanese subpopulation with resectable NSCLC, similar to the global population.