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
4526 - Long-term outcome of neoadjuvant tyrosine kinase inhibitors (TKI) in locally advanced dermatofibrosarcoma protuberans (DFSP)
Presenter: Jessica Beaziz
Session: Poster Display session 1
Resources:
Abstract
1214 - Neo-adjuvant (NA) Imatinib for gastrointestinal stromal tumours (GISTs): What is the optimal length of treatment?
Presenter: Tom Wilson
Session: Poster Display session 1
Resources:
Abstract
2690 - Gastrointestinal Stromal Tumours (GIST) in adolescents and young adults (AYA)
Presenter: Nikki Ijzerman
Session: Poster Display session 1
Resources:
Abstract
4558 - Radiomics improves response evaluation for desmoid tumors treated with chemotherapy
Presenter: Amandine Crombe
Session: Poster Display session 1
Resources:
Abstract
2751 - Radiomics of gastrointestinal stromal tumors; risk classification based on computed tomography images – a pilot study
Presenter: Milea Timbergen
Session: Poster Display session 1
Resources:
Abstract
2737 - Differentiating well-differentiated liposarcomas from lipomas using a radiomics approach
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
1282 - The immune landscape of chondrosarcoma reveals an anti inflammatory environment
Presenter: Iseulys Richert
Session: Poster Display session 1
Resources:
Abstract
1572 - Impact of Immunotherapy and Targeted Therapy on Tumor Growth Rate in Sarcoma
Presenter: Esmail Al-ezzi
Session: Poster Display session 1
Resources:
Abstract
3414 - DNA methylation profiles of angiosarcoma subtypes.
Presenter: Marije Weidema
Session: Poster Display session 1
Resources:
Abstract
3411 - Prognostic significance of circulating PD-1, PD-L1, pan-BTN3As and BTN3A1 in patients with metastatic gastrointestinal stromal tumors (mGISTs)
Presenter: Daniele Fanale
Session: Poster Display session 1
Resources:
Abstract