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
5823 - Pulmonary tumor-draining vein exosomal lincRNA-p21 levels impacts non-small cell lung cancer prognosis
Presenter: Joan Castellano
Session: Poster Display session 1
Resources:
Abstract
1842 - Immunological impact of surgery in NSCLC patients
Presenter: Akitoshi Yanagihara
Session: Poster Display session 1
Resources:
Abstract
4124 - The prognostic value of selected immunological panel in predicting the prognosis of early-stage resectable non-small cell lung cancer
Presenter: Sha Zhao
Session: Poster Display session 1
Resources:
Abstract
4468 - Genomic Heterogeneity and Clonality Analysis of Multiple synchronous lung cancers (MSLCs)
Presenter: Fachen Zhou
Session: Poster Display session 1
Resources:
Abstract
5547 - Analysis of immunosuppressive factors produced by tumorspheres in NSCLC. Prognostic value of Galectin-3 in adenocarcinoma
Presenter: Susana Torres Martinez
Session: Poster Display session 1
Resources:
Abstract
1658 - Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small-cell lung cancer (NSCLC) after complete tumour resection
Presenter: Masahiro Tsuboi
Session: Poster Display session 1
Resources:
Abstract
1535 - EGFR mutation is not a prognostic factor in completely resected lymph node–negative pulmonary adenocarcinoma (LNNPA)
Presenter: Nussara Leeladejkul
Session: Poster Display session 1
Resources:
Abstract
3262 - Prognostic significance of elements of the adaptive immunity in the microenvironment of early-stage non small cell lung cancer
Presenter: Aliki Liakea
Session: Poster Display session 1
Resources:
Abstract
4643 - Combined immunoscore for prognostic stratification of early stage NSCLC patients
Presenter: Giulia Pasello
Session: Poster Display session 1
Resources:
Abstract
4819 - Radiation-induced lung injury and misdiagnosis rate after SBRT
Presenter: Xiaolong Fu
Session: Poster Display session 1
Resources:
Abstract