Abstract 5919
Background
Nivolumab demonstrated overall survival (OS) benefit over docetaxel in patients (pts) with pre-treated squamous (SQ) and non-SQ (NSQ) NSCLC in 3 phase III clinical trials. We investigated US real-world outcomes of pts treated with nivolumab after ≥1 prior systemic therapy in predominantly community-based clinical practice.
Methods
This retrospective analysis of clinical electronic health record data in the Flatiron Health database included adult pts with advanced NSCLC receiving nivolumab monotherapy in second or later line (2L+) treatment between Mar 1, 2015 and Dec 31, 2018 (SQ) or Oct 1, 2015 and Dec 31, 2018 (NSQ). The index date was the start date of nivolumab. Prior treatment with ≥1 platinum-based and, if indicated, targeted therapy was required for inclusion. Pts with primary cancers other than NSCLC or who had received prior immunotherapy were excluded. Median (95% confidence interval [CI]) OS and progression-free survival (PFS) from index were estimated using Kaplan–Meier methodology in pt subgroups by histology.
Results
Of 3023 pts included in the analysis, 65.2% and 34.8% had NSQ and SQ histology, respectively. In the 2 groups at index, median age (range) was 68 (21–84) yrs and 70 (36–84) yrs, 51% and 63% were male, 11.3% and 5.9% had brain metastasis, 19.7% and 22.1% had ECOG PS ≥ 2 (∼26% had missing PS data in both groups). Most pts received nivolumab as 2L (NSQ 83.4% and SQ 85.3%); pts receiving nivolumab as 3L and 4L were included. Survival outcomes are reported in the Table.Table:
1498P
Survival outcomes of pts receiving 2L+ nivolumab monotherapy | |||||||
---|---|---|---|---|---|---|---|
OS | PFS | ||||||
n | Median (95% CI), months | 12-month rate, % | 18-month rate, % | Median (95% CI), months | 12-month rate, % | 18-month rate, % | |
NSQ | 1972 | 8.5 (7.9–9.3) | 40 | 31 | 3.2 (3.0–3.5) | 17 | 12 |
SQ | 1051 | 7.4 (6.8–8.5) | 36 | 24 | 3.0 (2.8–3.3) | 15 | 10 |
Conclusions
Pts receiving 2L+ nivolumab monotherapy for advanced NSQ and SQ NSCLC in US real-world clinical practice had numerically lower OS than pts in registrational trials, likely due to inclusion of pts with more impaired function. PFS was similar to that in registrational trials, but may be measured differently in routine clinical practice. Analyses with additional follow-up are planned to confirm long-term benefit of nivolumab in 2L+ NSCLC.
Clinical trial identification
Editorial acknowledgement
Leah Bernstein of Evidence Scientific Solutions Inc, funded by Bristol-Myers Squibb.
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb.
Disclosure
D.D. Stenehjem: Advisory / Consultancy, Research grant / Funding (institution): BMS; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Bioverativ; Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Salarius Pharmaceuticals; Advisory / Consultancy: Iterion Therapeutics; Advisory / Consultancy: GlycosBio. S.J. Lubinga: Full / Part-time employment: BMS. K. Gupte-Singh: Full / Part-time employment: BMS. Y. Zhang: Full / Part-time employment: BMS. K. Le Trong: Full / Part-time employment: BMS. J.R. Penrod: Full / Part-time employment: BMS.
Resources from the same session
860 - Dose differential modulation of the autophagic behavior of estrogen expressing breast carcinoma cells
Presenter: Mariam Fouad
Session: Poster Display session 1
Resources:
Abstract
2304 - Synthetic peptide of tumor–associated antigen L6 formulated with polymer-based adjuvant enhances anti-tumor effects in mice
Presenter: Shih-jen Liu
Session: Poster Display session 1
Resources:
Abstract
4419 - Improving detection level of somatic mosaicism in neurofibromatosis type 1
Presenter: Kristina Karandasheva
Session: Poster Display session 1
Resources:
Abstract
5283 - Preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationship of ABN401, a highly selective Met inhibitor, in gastric and non-small-cell lung cancer models
Presenter: JooSeok Kim
Session: Poster Display session 1
Resources:
Abstract
5488 - Transcription factors of Snail family in the regulation of resistance of breast cancer cells to hypoxic conditions
Presenter: Alvina Khamidullina
Session: Poster Display session 1
Resources:
Abstract
5417 - Metastasis is impaired by endothelial-specific Dll4 loss-of-function through inhibition of epithelial-to-mesenchymal transition and reduction of cancer stem cells and circulating tumour cells
Presenter: Liliana Mendonça
Session: Poster Display session 1
Resources:
Abstract
5494 - Identification of novel and known FGFR gene fusions in Chinese non-small cell lung cancer
Presenter: Weixin Zhao
Session: Poster Display session 1
Resources:
Abstract
3412 - WNT pathway mutations (APC/CTNNB1) and immune checkpoint inhibitors (ICI) response in metastatic non-small cell lung cancer (NSCLC) patients.
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 1
Resources:
Abstract
1815 - Leukocytosis as a negative prognostic factor in patients with lung cancer: Which subpopulation of leukocytes is responsible?
Presenter: Filip Kohutek
Session: Poster Display session 1
Resources:
Abstract
5022 - Identification of MET gene amplifications using next-generation sequencing in non-small cell lung cancer patients
Presenter: Sergi Clavé
Session: Poster Display session 1
Resources:
Abstract