Impact of Prior mRNA COVID-19 Vaccination on PFS2 in NSCLC Patients Receiving Second-Line Immune Checkpoint Inhibitors: A Real-World Analysis

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Background: Immune checkpoint inhibitors (ICIs) targeting the PD-1 axis represent standard second-line therapy for metastatic non-small cell lung cancer (NSCLC). Emerging data suggest that SARS-CoV-2 mRNA vaccines may enhance antitumor immunity through innate immune activation and type I interferon signaling, potentially sensitizing tumors to PD-1 blockade. The clinical impact of patients initiating second-line nivolumab remains unclear. Methods: In this retrospective single-center cohort study, 88 patients with recurrent stage IV NSCLC who received second-line nivolumab between 1 January 2023 and 1 January 2026 were analyzed. Vaccination exposure was defined using a 6-month pre-treatment window prior to nivolumab initiation (T0). Patients were stratified according to receipt of ≥2 versus 0–1 mRNA COVID-19 vaccine doses within the 6 months preceding T0 (n = 45 and n = 43, respectively). The primary endpoint was progression-free survival from nivolumab initiation (PFS2). Survival outcomes were estimated using the Kaplan–Meier method and evaluated using Cox regression models. Results: With a median follow-up of 22.4 months, median PFS2 for the overall cohort was 11.1 months (95% CI, 9.4–15.1). Patients receiving ≥2 mRNA doses had significantly longer PFS2 than those receiving 0–1 dose (14.0 vs. 9.6 months; p = 0.04). In multivariable analysis, ≥2 doses were independently associated with reduced risk of progression or death (aHR 0.52, 95% CI 0.31–0.88; p = 0.01). Non-adenocarcinoma histology and baseline brain metastasis were independently associated with shorter PFS2. Conclusions: Receipt of ≥2 mRNA vaccine doses within 6 months before nivolumab initiation was independently associated with prolonged PFS2 in metastatic NSCLC. Prospective multicenter validation is warranted.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.