Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States

Abstract

Background: Nivolumab demonstrated overall survival (OS) benefit over docetaxel in patients (pts) with pre-treated squamous (SQ) and non-SQ (NSQ) NSCLC in 3 phase III clinical trials. We investigated US real-world outcomes of pts treated with nivolumab after ≥1 prior systemic therapy in predominantly community-based clinical practice. Methods: This retrospective analysis of clinical electronic health record data in the Flatiron Health database included adult pts with advanced NSCLC receiving nivolumab monotherapy in second or later line (2L+) treatment between Mar 1, 2015 and Dec 31, 2018 (SQ) or Oct 1, 2015 and Dec 31, 2018 (NSQ). The index date was the start date of nivolumab. Prior treatment with ≤1 platinum-based and, if indicated, targeted therapy was required for inclusion. Pts with primary cancers other than NSCLC or who had received prior immunotherapy were excluded. Median (95% confidence interval [CI]) OS and progression-free survival (PFS) from index were estimated using Kaplan- Meier methodology in pt subgroups by histology. Results: Of 3023 pts included in the analysis, 65.2% and 34.8% had NSQ and SQ histology, respectively. In the 2 groups at index, median age (range) was 68 (21-84) yrs and 70 (36-84) yrs, 51% and 63% were male, 11.3% and 5.9%had brain metastasis, 19.7% and 22.1% had ECOG PS≥2 (∼26% had missing PS data in both groups). Most pts received nivolumab as 2L (NSQ 83.4% and SQ 85.3%); pts receiving nivolumab as 3L and 4L were included. Survival outcomes are reported in the Table. Conclusions: Pts receiving 2L+nivolumab monotherapy for advanced NSQ and SQ NSCLC in US real-world clinical practice had numerically lower OS than pts in registrational trials, likely due to inclusion of pts with more impaired function. PFS was similar to that in registrational trials, but may be measured differently in routine clinical practice. Analyses with additional follow-up are planned to confirm long-term benefit of nivolumab in 2L+NSCLC. (Table Presented) .