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Poster Display session 1

5128 - IO-Synthesise NSCLC: A pooled analysis of real-world survival outcomes for non-small cell lung cancer patients treated with nivolumab in France and Germany

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Adrien Dixmier

Citation

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

Authors

A. Dixmier1, B. Asselain2, F. Barlesi3, D. Debieuvre4, C. Audigier Valette5, A. Gröschel6, S. Gütz7, R. Liersch8, D. Moro-Sibilot9, H. Müller-Huesmann10, M. Perol11, C. Raspaud12, C. Schulte13, H. Schulz14, C. Schumann15, V. Allan16, C.Y. Calvet17, K.J. Rothnie18, V. Wünsch19, M. Sebastian20

Author affiliations

  • 1 Pneumology, C.H.R. Orleans - La Source, 45100 - Orleans/FR
  • 2 Biostatistics, Institut Curie, 75005 - Paris/FR
  • 3 Faculté De Médecine Nord, Aix-Marseille University, 13015 - Marseille/FR
  • 4 Pneumology, Hopital Emile Muller, 68100 - Mulhouse/FR
  • 5 Pneumology, Hospital Sainte Musse, 83100 - Toulon/FR
  • 6 Klinik Für Innere Medizin Ii - Pneumologie Und Beatmungsmedizin, Clemenshospital, Münster/DE
  • 7 Zentrum Für Innere Medizin, Ev. Diakonissenkrankenhaus gGmbH, Leipzig/DE
  • 8 Hämatologie Und Onkologie, Hämatologische-Onkologische Gemeinschaftspraxis, 48149 - Münster/DE
  • 9 Pneumologie, CHU Grenoble, 38700 - La Tronche/FR
  • 10 Klinik Für Hämatologie Und Onkologie, Brüderkrankenhaus St. Josef, Paderborn/DE
  • 11 Department Of Medical Oncology, Léon Bérard Cancer Center, 69008 - Lyon/FR
  • 12 Pneumology, Clinique Pasteur, 31076 - Toulouse/FR
  • 13 Gemeinschaftspraxis Für Hämatologie Und Onkologie, Gemeinschaftspraxis für Hämatologie und Onkologie, Dortmund/DE
  • 14 Praxis Internistischer Onkologie Und Hämatologie,, Praxis Internistischer Onkologie und Hämatologie,, Frechen/DE
  • 15 Clinic For Pneumology, Thoracic Oncology, Sleep- And Respiratory Critical Care, Kempten-Oberallgaeu Hospitals, 87439 - Kempten/DE
  • 16 Center For Observational Research And Data Science, Bristol-Myers Squibb, UB8 1DH - Uxbridge/GB
  • 17 Medical Affairs France, Bristol-Myers Squibb, Paris/FR
  • 18 Centre For Observational Research And Data Science, Bristol Myers Squibb, UB8 1DH - London/GB
  • 19 Medical Affairs Germany, Bristol-Myers Squibb, Munich/DE
  • 20 Medizinische Klinik Ii, Abteilung Hämatologie, Medizinische Onkologie, Universitätsklinikum Frankfurt,, Frankfurt/DE

Resources

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Abstract 5128

Background

Large-scale multi-national data are lacking on the real world use and outcomes of nivolumab for advanced non-small cell lung cancer (NSCLC). I-O Synthesise NSCLC aims to pool and collectively analyse data from independent study cohorts of real world patients treated with nivolumab for advanced NSCLC. In the present study, we evaluated the real-world benefit of nivolumab in patients with lung cancer from two prospective multi-centre observational cohorts studies [in France (EVIDENS, NCT03382496)) and Germany (ENLARGE, NCT02910999)].

Methods

Individual patient data from EVIDENS and ENLARGE were pooled and harmonised in terms of inclusion criteria and variable definitions. Eligible patients had locally advanced or metastatic (stage IIIb/IV) NSCLC, were treated with nivolumab following at least one prior systemic therapy and without diagnoses of other primary cancers. Overall survival (OS) was calculated, including according to histology, using the Kaplan-Meier method from nivolumab initiation date until death or censoring on the last visit date or study withdrawal.

Results

Following harmonisation of inclusion criteria, 1837 patients (EVIDENS, 1209 patients; ENLARGE, 628 patients) from 225 centres across France and Germany were included in the pooled sample. Baseline characteristics were: median age 65 years, 68% male, 83% ECOG 0-1, 74% 1 prior line of therapy, 68% non-squamous histology, 94% stage IV, 22% with brain metastases (treated or untreated), and 2.8% active autoimmune disease. At the time of analysis over 90% of patients had at least six-months of follow-up. Median OS was 11.5 (10.4, 12.2) months, 10.2 (8.6, 11.5) for squamous and 12.2 (10.8, 13.2) for non-squamous disease. The one-year OS rate was 49%, 51% for non-squamous, and 45% for squamous histology.

Conclusions

In this large-scale study of nivolumab in pre-treated advanced NSCLC, real-world outcomes were consistent with pivotal nivolumab trials.

Clinical trial identification

NCT03382496; NCT02910999.

Editorial acknowledgement

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Disclosure

A. Dixmier: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis. B. Asselain: Advisory / Consultancy: Bristol-Myers Squibb. D. Debieuvre: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Chugai; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): GSK; Research grant / Funding (institution): Pierre Fabre; Research grant / Funding (institution): Mundipharma . C. Audigier Valette: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer–Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche. A. Gröschel: Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: MSD. S. Gütz: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Takeda; Honoraria (self): Boehringer Ingelheim. D. Moro-Sibilot: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy: Boehringer; Advisory / Consultancy: AbbVie; Advisory / Consultancy: Takeda. M. Perol: Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: BMS; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Takeda; Advisory / Consultancy: Clovis ; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca. C. Schumann: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche. V. Allan: Full / Part-time employment: Bristol-Myers Squibb. C.Y. Calvet: Full / Part-time employment: Bristol-Myers Squibb. K.J. Rothnie: Full / Part-time employment: Bristol-Myers Squibb. V. Wünsch: Full / Part-time employment: Bristol-Myers Squibb. M. Sebastian: Honoraria (self), Advisory / Consultancy: AbbVie; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Medio-launum; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Takeda. All other authors have declared no conflicts of interest.

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