KEY TAKEAWAYS
- The EVIDENS observational study aimed to investigate nivolumab’s long-term effectiveness, safety, and QoL outcomes in metastatic NSCLC pts.
- Researchers confirmed the nivolumab’s efficacy, safety, and QoL impact, guiding practice with long-term follow-up and subgroup insights to be explored later.
EVIDENS, a prospective, non-interventional, multicenter study, was conducted by Fabrice Barlesi and his team to evaluate using nivolumab in metastatic non-small cell lung cancer (NSCLC). The study was initiated before the availability of immunotherapy in the first-line setting. In this final analysis, the results of the study are presented, with a focus on outcomes observed at the 36-month follow-up.
Researchers performed an inclusive analysis of adults diagnosed with pathologically confirmed lung cancer who initiated nivolumab treatment between October 2016 and November 2017. The study followed patients (pts) until December 2020, documenting patient characteristics at diagnosis and nivolumab initiation. Survival analysis employed the Kaplan-Meier method, while quality of life was assessed using the EuroQol-5D-3 Level (EQ-5D-3L) questionnaire and visual analog scale (VAS).
About 1423 pts diagnosed with NSCLC (69% male, median age 66 years) were included in the analysis. At the initiation of nivolumab, pts had an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0–1 (83.0%), 69.1% exhibited non-squamous histology, (91.5%) were diagnosed with stage IV disease, and (89.8%) were current/former smokers; 19.9% presented with brain metastases. Almost all pts (99.7%) had prior chemotherapy, and nivolumab served as second-line therapy for 73.5% of pts, with a median treatment duration of 73.0 days.
Median overall survival (OS) was 11.0 months (95%CI: 9.8–12.2), and progression-free survival (PFS) was 3.0 months (95% CI: 2.6–3.2). In multivariate analyses, pts with squamous NSCLC, liver metastasis, ECOG-PS ≥2, or those who never smoked faced a significantly higher risk of shorter OS and PFS. Age, brain metastasis, or corticosteroid therapy at nivolumab initiation did not impact OS and PFS. The overall response rate stood at 12.1%, with a median duration of response of 13 months.
Treatment-related adverse events (TRAEs) occurred in 35.7% (any grade), 8.0% (grade 3), and 0.8% (grade 4) of pts. Notably, pts continuously treated with nivolumab demonstrated better EQ-5D-3L VAS scores than those who discontinued treatment.
The study concluded that the final analysis of EVIDENS affirms the efficacy, safety, and effect on QoL of nivolumab, aligning with findings from clinical trials. The insights derived, with extended follow-up and subgroup analyses indicating potential heightened benefits in specific patient groups, contribute valuable information for informing clinical practice. Further exploration of these conclusions is suggested in the LIST study.
The study is sponsored by the Bristol-Myers Squibb
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT03382496
Barlesi F, et al. (2023). “Final Analysis of the French Real-World Study EVIDENS: Effectiveness, Safety & Quality of Life At 36 Months of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)” Presented at ESMO IO 2023 (Abstract 78P).
