78P - 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)

Background

EVIDENS was a prospective, non-interventional, multicenter study evaluating nivolumab in metastatic NSCLC, initiated before immunotherapy was available in first-line. This final analysis presents results at 36-months’ follow-up.

Methods

Adults with pathologically confirmed lung cancer initiating nivolumab between October 2016–November 2017 were included and followed up until December 2020. Patient characteristics were recorded at diagnosis & nivolumab initiation. Survival was evaluated with the Kaplan-Meier method & quality of life (QoL) with the EuroQol-5D-3 Level (EQ-5D-3L) questionnaire and visual analog scale (VAS).

Results

A total of 1423 patients with NSCLC (69% male, median age 66 years) were included in this analysis. At nivolumab initiation, most patients had an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0–1 (83.0%), non-squamous histology (69.1%), stage IV disease (91.5%) & were current/former smokers (89.8%); 19.9% had brain metastases. Most patients (99.7%) had previously received chemotherapy; nivolumab was second line therapy in 73.5% of patients with a median treatment duration of 73.0 days. Median overall survival (OS) was 11.0 months (95%CI: 9.8–12.2) & progression-free survival (PFS) 3.0 months (95% CI: 2.6–3.2). In multivariate analyses, patients with squamous NSCLC, liver metastasis, ECOG-PS ≥2 or who never smoked had significantly higher risk of shorter OS & PFS. Age, brain metastasis, or corticosteroid therapy at nivolumab initiation had no effect on OS & PFS. The overall response rate was 12.1%; median duration of response was 13 months. Treatment-related adverse events occurred in 35.7% (any grade), 8.0% (grade 3) and 0.8% (grade 4) of patients. Patients continuously treated with nivolumab had better EQ-5D-3L VAS scores than those who discontinued.

Conclusions

EVIDENS final analysis confirm the effectiveness, safety & effect on QoL of nivolumab reported in clinical trials. They help inform clinical practice by virtue of a long-term follow-up & subgroup analyses suggesting greater benefit in certain patients. This conclusion might be explored further in the LIST study.

Clinical trial identification

NCT03382496.

Editorial acknowledgement

Tracy Harrison of Springer Healthcare Communications provided editing of the abstract prior to submission. Yaacoub Khalife of Bristol Myers Squibb France Medical Oncology Department provided editing of the abstract prior to submission.

Legal entity responsible for the study

The authors.

Funding

Bristol Myers Squibb.

Disclosure

F. Barlesi: Financial Interests, Institutional, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann-La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi Aventis, Seattle Genetics, Takeda, AbbVie, ACEA, Amgen, Eisai, Ignyta; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd., Innate Pharma, Mirati. D. Debieuvre: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Janssen, Pfizer, OSE Immunotherapeutics, Novartis, Sanofi Aventis, Amgen, Roche, Ipsen; Financial Interests, Personal, Invited Speaker: Gilead, Takeda; Financial Interests, Personal, Coordinating PI: Pfizer; Financial Interests, Institutional, Funding: Roche, AstraZeneca, Janssen, MSD, Pfizer, BMS, Lilly, Boehringer Ingelheim, GSK, Chugaï, Chiesi, Novartis, Takeda, Bayer, Sanofi Aventis. J.B. Auliac: Financial Interests, Personal, Speaker, Consultant, Advisor: Sanofi, Janssen, AstraZeneca, Takeda, BMS, MSD. D. Moro-Sibilot: Financial Interests, Personal, Advisory Board: Lilly, Roche, BMS, MSD, AbbVie, Becton Dickinson, Pfizer, Takeda, AstraZeneca, Boehringer Ingelheim, Novartis, GSK, Sanofi; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Funding, IFCT clinical trials: Pfizer; Financial Interests, Institutional, Funding: Roche, AbbVie, AstraZeneca. B. Asselain: Financial Interests, Personal, Other: BMS, AstraZeneca, Pierre Fabre, Servier, Daiichi Sankyo, Gilead. C. Audigier-Valette: Financial Interests, Personal, Advisory Board: Roche, BMS, MSD, AstraZeneca, Sanofi, Janssen; Financial Interests, Personal, Speaker, Consultant, Advisor: Pfizer. F. Breliier, E. Gauthier, D. Reynaud: Financial Interests, Personal, Full or part-time Employment: BMS. F. Cotté: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks/Shares: BMS. M. Pérol: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, Janssen, GSK, Eisai, Ipsen; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Boehringer Ingelheim, Takeda, Illumina, Pfizer, Medscape; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Takeda, Boehringer Ingelheim; Financial Interests, Personal, Steering Committee Member: Roche; Financial Interests, Personal, Other, DMSB: Roche. All other authors have declared no conflicts of interest.