Two-year survival with nivolumab in previously treated, advanced non-small cell lung cancer: A pooled analysis of real-world patients from France, Germany and Canada.

e21714 Background: Data from clinical studies demonstrate a long-term survival benefit of nivolumab in previously treated advanced non-small cell lung cancer (NSCLC) patients with overall survival (OS) at two-years of 27%, however real-world data are limited. We report OS in patients pooled from two prospective multi-centre observational cohort studies in France (EVIDENS, NCT03382496) and Germany (ENLARGE, NCT02910999) and a third retrospective registry of patients treated through expanded access to nivolumab in Canada. Methods: Individual patient data from each cohort were pooled and harmonised in eligibility criteria and variable definitions. Included patients had locally advanced or metastatic (stage IIIB/IV) NSCLC, received nivolumab after at least one prior systemic therapy and had no other concurrent primary cancers. OS was estimated from nivolumab initiation until death or censoring using Kaplan-Meier method. Equality of survival distributions across cohorts was measured using log-rank test. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated from unstratified Cox proportional hazards regression models to explore survival among subgroups. Data on bone and liver metastases, PD-L1 and safety were available and analysed for France and Germany only. Results: Data from 2582 patients (48% France; 34% Germany; 18% Canada) were pooled. Baseline characteristics were: median age 66 years, 64% male, 82% ECOG 0-1, 69% 1 prior line of therapy, 68% non-squamous histology, and 18% with brain metastases (treated or untreated). Median follow-up was 8 months. No difference in OS was observed between countries. The 2-year OS was 28% (95%CI 25-31) for all patients, 26% (95%CI 21-31) for squamous histology and 29% (95%CI 26-33) for non-squamous histology. Bone metastases (HR 1.42; 95%CI 1.26-1.60; P= < .0001) and liver metastases (HR 1.60; 95%CI 1.39-1.85; P= < .0001) were associated with shorter survival, while ECOG PS 0-1 (HR 0.61; 95%CI 0.52-0.71; P= < .0001) and PD-L1 positivity (HR 0.75; 95%CI 0.60-0.93; P= < .0001) were associated with prolonged survival. Rates of any grade and grade 3/4 treatment-related adverse events (TRAE) were 32% and 7% respectively. Conclusions: In this three-country pooled analysis of nivolumab in previously treated advanced NSCLC, real-world overall survival at 2-years was consistent with pivotal nivolumab trials overall and in subgroups. Rates of grade 3/4 TRAEs were comparable, but events of lower grade may be underreported in the real world.