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Poster Display session 1

4305 - Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: Updated survival and subgroup analysis from the real-world EVIDENS study

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Fabrice Barlesi

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

F. Barlesi1, A. Dixmier2, D. Debieuvre3, C. Raspaud4, J.B. Auliac5, N. Benoit6, P. Bombaron7, D. Moro-Sibilot8, C. Audigier-Valette9, B. Asselain10, P. Lamoureux11, F. Cotté12, V. Allan13, M. Daumont12, N. Ozan14, C. Calvet14, M. Perol15

Author affiliations

  • 1 Faculté De Médecine Nord, Aix-Marseille University, 13015 - Marseille/FR
  • 2 Pneumology, C.H.R. Orleans - La Source, 45100 - Orleans/FR
  • 3 Respiratory Medicine Department, Hopital Emile Muller, 68100 - Mulhouse/FR
  • 4 Pneumology, Clinique Pasteur, 31076 - Toulouse/FR
  • 5 Pneumology, CH François Quesnay, 78201 - Mantes La Jolie/FR
  • 6 Pneumology, Clinique de l’Europe, 80000 - Amiens/FR
  • 7 Pneumology, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 8 Pneumologie, CHU Grenoble, 38700 - La Tronche/FR
  • 9 Pneumo-oncology, Hôpital Sainte Musse, Toulon/FR
  • 10 Biostatistics, Institut Curie, 75005 - Paris/FR
  • 11 Medical, Bristol-Myers Squibb, 54500 - Vandoeuvre les Nancy/FR
  • 12 Heor, Bristol-Myers Squibb, 92500 - Rueil-Malmaison/FR
  • 13 Center For Observational Research & Data Science, Bristol Myers Squibb, UB8 1DH - Uxbridge/GB
  • 14 Medical, Bristol-Myers Squibb, 92500 - Rueil-Malmaison/FR
  • 15 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR

Resources

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Abstract 4305

Background

The EVIDENS study aims to describe clinical characteristics and health-related quality of life (HRQoL) of lung cancer patients treated with nivolumab in real-life in France and to assess its effectiveness and safety.

Methods

EVIDENS is an observational, multicenter, longitudinal cohort study of adult lung cancer patients treated with nivolumab. Survival was assessed using the Kaplan-Meier method and health-related quality of life (HRQoL) was assessed using EQ-5D-3L questionnaire.

Results

A total of 1,462 lung cancer patients were enrolled in the study from Oct 2016 to Nov 2017 in 146 French centers. Previous reports with a 8-month minimum follow-up showed that baseline patient and tumor characteristics from EVIDENS were representative of a standard advanced NSCLC population and that nivolumab was mostly administered as a 2nd line regimen. Median PFS and median OS was 2.8 months (95% CI: 2.6-3.0) and 10 months (95% CI: 9.2-11.0), respectively. Adverse events occurred in 440 patients (31.6%), including 98 patients (7.0%) with grade 3-4 events. Concerning HRQoL, mean change of visual analog score from baseline was statistically significant at 9 and 12 months and minimal important difference was achieved at 12 months for the squamous population. The analysis presented during the congress will include updated effectiveness, safety and HRQoL data as well as subgroups of interest (e.g. brain metastasis, age, prior radiotherapy) with a 17-month minimum follow-up.

Conclusions

TTo date, EVIDENS is the largest prospective observational study of nivolumab in lung cancer patients confirming effectiveness and safety in the real world setting. This updated analysis provides new insights on the experience of nivolumab over a period of longer follow-up and, for the first time, in clinically important subgroups of interest.

Clinical trial identification

NCT03382496.

Editorial acknowledgement

Legal entity responsible for the study

Bristol-Myers Squibb France.

Funding

Bristol-Myers Squibb France.

Disclosure

A. Dixmier: Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: Lilly. D. Debieuvre: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Chugaï; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): GSK; Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Mundipharma. J.B. Auliac: Advisory / Consultancy, Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory / Consultancy: Roche. N. Benoit: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: AstraZeneca. D. Moro-Sibilot: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): AbbVie; Advisory / Consultancy: Takeda. C. Audigier-Valette: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (institution), Advisory / Consultancy: Roche. B. Asselain: Advisory / Consultancy: Bristol-Myers Squibb. P. Lamoureux: Full / Part-time employment: Bristol-Myers Squibb. F. Cotté: Full / Part-time employment: Bristol-Myers Squibb. V. Allan: Full / Part-time employment: Bristol-Myers Squibb. M. Daumont: Full / Part-time employment: Bristol-Myers Squibb. N. Ozan: Full / Part-time employment: Bristol-Myers Squibb. C. Calvet: Full / Part-time employment: Bristol-Myers Squibb. M. Perol: Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Takeda; Advisory / Consultancy: Clovis. All other authors have declared no conflicts of interest.

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