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.
Resources from the same session
3181 - Effects of Three Products in the Prevention and Treatment of Chemotherapy and Radiation Therapy-Induced Oral Mucositis
Presenter: Francesca Zannier
Session: Poster Display session 1
Resources:
Abstract
2433 - Boiling Histotripsy-induced Mechanical Ablation Modulates Tumour Microenvironment by Promoting Immunogenic Cell Death of Cancers
Presenter: Cheol-Hee Shin
Session: Poster Display session 1
Resources:
Abstract
2663 - The bacterial receptor NOD2 mediates LGR5+ intestinal stem cells protection against irradiation via mitophagy activation
Presenter: Antonin Levy
Session: Poster Display session 1
Resources:
Abstract
3213 - Pulse mode irradiation regimen of PDT results in high progression free and overall survival in mice with model tumor
Presenter: Alexey Bogdanov
Session: Poster Display session 1
Resources:
Abstract
3722 - Proton-sensitizing effect of small molecule inhibitor of P300 histone acetyltransferase C646 in human pancreatic cancer cells.
Presenter: Sungwon Shin
Session: Poster Display session 1
Resources:
Abstract
5805 - Red-Blood-Cell-Membrane-Enveloped Magnetic Nanoclusters as a Biomimetic Theranostic Nanoplatform for Bimodal Imaging Guided Cancer Photothermal Therapy
Presenter: sheng wang
Session: Poster Display session 1
Resources:
Abstract
5251 - Urine cell-free and extracellular vesicle cargo miRNAs as biomarkers for prostate cancer diagnosis
Presenter: Ivan Zaporozhchenko
Session: Poster Display session 1
Resources:
Abstract
3657 - Parkin, APEX1 and BCL2L1 Tissue Expression in Southern Brazilian Patients with Different Breast Cancer Molecular Subtypes
Presenter: Bianca Cabral
Session: Poster Display session 1
Resources:
Abstract
2839 - Obesity and prognosis in breast cancer
Presenter: Noha Ibrahim
Session: Poster Display session 1
Resources:
Abstract
5132 - SIPA1 is a modulator of HGF induced tumor metastasis via the regulation of tight junctions in lung adenocarcinoma cells
Presenter: Chang Liu
Session: Poster Display session 1
Resources:
Abstract