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

Abstract

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; p = 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.

Keywords: EVIDENS; France; nivolumab; non-small cell lung cancer; observational study.

Figure 1.

Kaplan – Meier estimates of overall survival (a) in all patients and (b) by histological subtype.

Figure 2.

Multivariate Cox proportional-hazards regression model for the association of patient characteristics at nivolumab initiation with overall survival.

Figure 3.

Kaplan – Meier estimates of progression-free survival (a) in all patients and (b) by histological subtype.

Figure 4.

Change in EQ-VAS scores from baseline to 24 months in the overall population (N = 1,423). Values for 30 and 36 months are not shown as the questionnaire completion rates were considered too low. Box represents IQR (Q1, Q3), the black line is median, the whiskers are 1.5 times the IQR, the red circles are minimum and maximum, and the red lines indicate ±7 the MID.