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
2182 - Evaluating the prevalence of the expression of PD-L1 in NSCLC specimens with short-duration formalin fixation using IHC 22C3 pharmDx
Presenter: Keiichi Ota
Session: Poster Display session 1
Resources:
Abstract
5255 - [18F]-FDG PET/CT in predicting PD-L1 status in nasopharyngeal carcinoma
Presenter: Liang Zhao
Session: Poster Display session 1
Resources:
Abstract
4910 - Expression of PD-L1 in Chinese Patients with Common Cancers
Presenter: Min Zheng
Session: Poster Display session 1
Resources:
Abstract
4227 - The clearance of EGF by tumor-associated macrophages is suppressed by chemotherapeutic agent cisplatin
Presenter: Irina Larionova
Session: Poster Display session 1
Resources:
Abstract
5222 - VHIO-300 and a thousand one nights, a tale of Precision Medicine
Presenter: Ginevra Caratù
Session: Poster Display session 1
Resources:
Abstract
5668 - Matched Whole-Genome Sequencing and Whole-Exome Sequencing with Circulating Tumor DNA (ctDNA) Analysis are complementary modalities in clinical practice
Presenter: Robin Imperial
Session: Poster Display session 1
Resources:
Abstract
5772 - Exploring the role of genes associated with familial cancer syndromes on the development of multiple primary tumors
Presenter: Atanaska Mitkova
Session: Poster Display session 1
Resources:
Abstract
4784 - Doxorubicin resistance: early and advanced tumors can use two different strategies based on initial and profound abnormalities in microRNA expression signature
Presenter: Volodymyr Halytskiy
Session: Poster Display session 1
Resources:
Abstract
3456 - From tumor transcriptomes to underlying cell type proportions to better predict prognosis and response to treatments
Presenter: Yuna Blum
Session: Poster Display session 1
Resources:
Abstract
4976 - Optimization of automated germline DNA extraction from non-tumoral formalin-fixed paraffin embedded (FFPE) tissues
Presenter: Omar Youssef
Session: Poster Display session 1
Resources:
Abstract