EVIDENS: An observational study of nivolumab-treated patients in advanced non-small cell lung cancer (NSCLC) in a real-world setting: Initial results on 1394 patients

Background: Nivolumab demonstrated efficacy and safety in patients previously treated for advanced NSCLC in two phase 3 trials: CheckMate 017 and 057. Real‐world data in a large unselected population are needed to support these results. EVIDENS aims to describe clinical characteristics of NSCLC patients treated with nivolumab in real-life in France and to assess its efficacy and safety. Methods: EVIDENS is an observational, multicenter, longitudinal cohort study of adult NSCLC patients treated with nivolumab in a representative sample of general hospitals, university hospitals and private clinics in France. From Dec 2016 to Nov 2017, 186 sites participated in the study. We report here a pre-planned analysis including patients with confirmed NSCLC treated with at least one dose of nivolumab with a minimum of 6 months of follow-up. Kaplan-Meier estimates were derived for PFS and medians with their 95% confidence intervals. Results: At data cut off April 20, 2018, 1394 NSCLC patients received nivolumab, including 434 (31.1%) with Squamous (Sq)-NSCLC and 960 (68.9%) with non-Sq-NSCLC. Baseline patient characteristics were representative of a standard advanced NSCLC population: median age 66.0 years (range 35-91), 69.2% men, 89.6% current and former smokers, 83.2% PS 0-1. 279 (20.0%) patients had brain metastases and 41 (2.9%) patients had active autoimmune disease. PD-L1 was tested in 187 patients and expressed (≥1%) in 121 (64.7%) patients. Of the 828 non-Sq NSCLC patients tested, 46 (5,5%) had EGFR mutations. Nivolumab was administered in 2nd and ≥3rd line for 74.4% and 25.3% of patients respectively. Median PFS since inclusion was 3 months (95%CI 2.96-3.61). Adverse events occurred in 885 (63.5%) patients, including 145 (10.4%) grade 3/4 events. Conclusions: These preliminary results of EVIDENS confirm both the activity and safety profile of nivolumab in the ≥2nd line setting in usual clinical practice, including patient populations under-represented in pivotal clinical trials. Outcomes over a longer follow-up period (minimum potential 12 months) and OS data will be presented during the congress. Clinical trial identification: NCT03382496. Legal entity responsible for the study: Bristol-Myers Squibb France. Funding: Bristol-Myers Squibb France. Disclosure: A. Dixmier: Bristol Myers Squibb, Roche. D. Debieuvre: Consulting: Roche; Honoraria : AstraZeneca, Chugai, Lilly, Roche, Novartis, Pfizer, MSD, BMS; Funding for research: Roche, AstraZeneca, Lilly, BMS, Boehringer Ingelheim, Chiesi, Chugai, Janssen, Pfizer, MSD, Novartis, GSK, Sandoz; Expertise (board): Roche, Boehringer Ingelheim, Pfizer, MSD, BMS, Novartis; Honoraria (congress invitation): Roche, Boehringer Ingelheim, Novartis, Pierre Fabre, Pfizer, Mundipharma, BMS. C. Raspaud: Novartis, Boehringer-Ingelheim, GSK, Chiesi, BMS, MSD, AstraZeneca, SOS O2, Agir Adom, Lilly. J.B. Auliac: Advisory board: BMS, Roche, AstraZeneca, Boehringer; Grant: BMS, Roche, AstraZeneca, Boehringer, MSD, Amgen, Pfizer. N. Benoit: BMS, AstraZeneca. P. Bombaron: BMS, Novartis, Boehringer Ingelheim, Roche, Amgen. B. Asselain: Scientific Committee, Speaker: BMS. A. Dumont, P. Lamoureux, N. Goyard: Employee: BMS. D. Moro-Sibilot: Advisory board: Roche, Pfizer, AstraZeneca, BMS, MSD, Lilly, Boehringer, Abbvie, Takeda Corporate; Sponsored research: Boehringer, Abbvie. M. Perol: Honoraria for Advisory Board: BMS. C. Audigier Valette: Principal investigator for clinical trials: AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche; Consulting/Advisory board: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, MSD, Pfizer, Roche; Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Pfizer, Roche. All other authors have declared no conflicts of interest.