Long-term outcomes of preoperative nivolumab with or without relatlimab in patients with resectable non-small-cell lung cancer (NEOpredict-Lung)

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BACKGROUND: Preoperative immunotherapy targeting PD-1/-L1 with chemotherapy induces histopathological responses and improves survival in patients with resectable non-small cell lung cancer (NSCLC). NEOpredict-Lung (NCT04205552) established the feasibility of dual blockade of PD-1 and LAG-3 immune checkpoints prior to curatively intended resection. Here we report extended follow-up, postoperative treatments and patterns of response and recurrence. PATIENTS AND METHODS: Patients with resectable NSCLC (stages IB-IIIA) were randomized to receive two doses nivolumab (240 mg, arm A) with or without relatlimab (80 mg, arm B) every 2 weeks. Overall and disease-free survival (OS, DFS) rates, response and recurrence patterns and subsequent therapies were evaluated. RESULTS: 60 patients were enrolled from March 2020 to July 2022. The present analysis was conducted per December 2024 with a median follow-up of 37.4 months. 45 patients were alive without disease recurrence,15 patients recurred (4 locoregional and 11 metastatic), and 7 patients died. The 3-year OS and DFS rates were 88.4 % and 73.3 % in arm A and 88.9 % and 60.3 % in arm B. Patients achieving major pathological response (≤10 % viable tumor cells in resected NSCLC) trended towards better DFS (HR 0.35; 95 % CI, 0.1-1.19). Downstaging was confirmed in 53.3 % of patients in arm A and in 66.7 % of patients in arm B. Nodal downstaging occurred in 28.6 % of patients with nodal disease in arm A and in 66.7 % of patients in arm B. CONCLUSIONS: Short course preoperative nivolumab with or without relatlimab showed encouraging efficacy and survival outcomes, which compare favorably with chemo-immunotherapy-based perioperative treatment regimens.

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