Final 3-year results from the EVIDENS study, an observational study of nivolumab in non-small cell lung cancer.

EVIDENS was a prospective, non-interventional, longitudinal study conducted in non-small cell lung cancer (NSCLC) patients receiving nivolumab in France. It recruited adults with pathologically confirmed NSCLC who initiated nivolumab between October 2016 and November 2017; the final results are reported here. Primary outcomes included baseline characteristics and 36-month overall survival (OS). Secondary outcomes included progression free survival (PFS), objective response rate (ORR), safety and health-related quality of life (HRQoL; assessed regardless of nivolumab continuation or interruption). Overall, 1423 patients were included in the analysis population (median age 66 years; non-squamous histology 69.1%; stage IV disease 91.5%; brain metastases 19.9%). Almost all patients (99.7%) had received prior chemotherapy, and most patients received nivolumab as second-line (73.5%) or later (26.1%) therapy. The 36-month OS rate was 19.7% (95% confidence interval [CI] 17.5-22.0); OS was significantly shorter in patients with squamous versus non-squamous tumors (9.8 [95% CI 8.6-11.2] months vs 11.8 [95% CI 10.2-13.2] months;  = 0.005). The 36-month PFS rate was 8.8% (95% CI 7.3-10.4). The 12-month investigator-assessed best ORR in the overall population was 20.4%. Eastern Cooperative Oncology Group performance status, smoking status, tumor histology, disease stage and liver metastasis independently predicted survival. Grade 3 and 4 treatment-related adverse events were reported in 8.0% and 0.8% of patients, respectively; eight treatment-related deaths occurred (0.005%). HRQoL was maintained with slight improvement throughout the study, without statistical significance. These results confirm that the real-world effectiveness and safety of nivolumab in these patients is similar to that observed in clinical trials.