Abstract 1276P
Background
Nivolumab, an anti-PD-1 antibody, demonstrated superior overall survival (OS) in phase III trials in patients previously treated for aNSCLC. The objective of UNIVOC was to describe in real-world setting the long-term outcomes of patients treated with nivolumab, overall and in three specific populations: elderly (80+ years), brain metastases (BMs), renal impaired.
Methods
Based on French National hospitals database, we constituted a retrospective cohort of all aNSCLC patients who initiated nivolumab in 2015-16 and were followed until Dec-18. Information on patients’ baseline characteristics (demographics, comorbidities, treatment history) was retrieved, and time to treatment discontinuation (TTD) and OS were estimated with Kaplan-Meier method.
Results
The overall cohort included 10,452 patients. Median age was 64 years, including 514 elderly patients (4.9%). At baseline, 1800 patients (17.2%) had BMs and 479 patients (4.6%) had renal impairment. Compared to younger patients, elderly presented with similar comorbidities but lower rates of BMs (5.6% vs. 17.8%; p<000.1). Patients with BMs were younger (median age: 60 vs 65 yrs; p<000.1) more frequently women (37.3% vs.27.3%; p<0.0001) than patients with no BMs. Patients with renal impairment presented higher rates of comorbidities than patients without renal impairment. Median TTD with nivolumab was 2.8 months in the overall, elderly and renal impaired populations, and 2.3 months in patients with BMs. In the overall population, median OS was 11.7 months [95%CI: 11.3–12.2] and 3-year OS rate was 19.1% [18.1%–20.2%]. Median OS and 3-year OS rates were 11.7 months [11.3–12.1] and 16.5% [11.6%–23.4%]) in elderly patients, 9.9 months [9.0–10.9] and 21.7% [19.4%–24.2%] in patients with BMs and 10.1 months [8.7–12.0] and 15.9% [11.8%–21.4%] in patients with renal impairment, respectively.
Conclusions
This large nationwide cohort reported narrow estimates of 3-year OS rate reaching 19%, in consistency with nivolumab phase III trials. Despite lower median OS in patients with BMs and renal impairment, long-term OS within special populations remained comparable to the overall population.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb.
Disclosure
M. Giaj Levra: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis. C.Y. Calvet, V. Grumberg, A-F. Gaudin, F-E. Cotté: Full/Part-time employment: Bristol-Myers Squibb. B. Jouaneton: Full/Part-time employment: HEVA. C. Chouaid: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD; Advisory/Consultancy: Pierre Fabre Oncology; Advisory/Consultancy: Lilly ; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis. All other authors have declared no conflicts of interest.