Safety and efficacy of nivolumab in previously treated patients with advanced non-small cell lung cancer: real world data from an expanded access program in Brazil

Objective: To assess the real-world efficacy and safety of nivolumab in patients with nonsmall cell lung cancer (NSCLC) treated through an expanded access program (EAP) in Brazil.Methods: This was a retrospective cohort study, conducted by the Latin American Cooperative Oncology Group and designated LACOG 0618, in which we analyzed data from 108 patients with NSCLC treated with nivolumab under the CA209-169 EAP across seven research sites in Brazil.Patients were eligible if they had stage IIIb/IV squamous or nonsquamous NSCLC with progression after platinum-based therapy and an Eastern Cooperative Oncology Group performance status ≤ 2. The primary endpoints were safety and efficacy, assessed via medical chart reviews.Results: The median age at nivolumab initiation was 62.5 years; most of the patients had a history of smoking and advanced disease at treatment onset.At a median follow-up of 19.9 months, median progression-free survival was 3.9 months (3.3 and 9.6 months for nonsquamous and squamous NSCLC, respectively) and median overall survival was 13.3 months (10.7 and 15.9 months for nonsquamous and squamous NSCLC, respectively).Immune-related adverse events were observed in 26.9% of the patients and were severe in 4.6%.Conclusions: Despite the poorer prognostic indicators in our sample of patients with NSCLC treated via the Brazilian nivolumab EAP, the median overall survival rate was slightly better than those reported in two previous phase III trials, whereas progressionfree survival was similar and the safety profile was consistent with that reported in those trials.Our findings confirm the effectiveness and safety of nivolumab in treating advanced NSCLC, even in patients who have received many lines of systemic therapy.