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
5054 - Inhibition of Rspo-Wnt pathway Facilitates Checkpoint Blockade Therapy by anti-RSPO3 antibody (DBPR117)
Presenter: John Hsu
Session: Poster Display session 1
Resources:
Abstract
3305 - A phase I dose-escalation and expansion trial of intratumorally administered CV8102, alone and in combination with anti-PD-1 in patients with advanced solid tumors
Presenter: Jürgen Krauss
Session: Poster Display session 1
Resources:
Abstract
5353 - Phase 1/2 Study of 9-ING-41, a small molecule selective Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors
Presenter: Benedito Carneiro
Session: Poster Display session 1
Resources:
Abstract
3946 - Trial in progress: a Phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors (NCT03447314).
Presenter: Aaron Hansen
Session: Poster Display session 1
Resources:
Abstract
3449 - Radiographic Phenotyping to Identify Intracranial Disseminated Recurrence in Brain metastases Treated With Radiosurgery Using Contrast-enhanced MR Imaging
Presenter: CheYu Hsu
Session: Poster Display session 1
Resources:
Abstract
4553 - Association between TP53 mutations and efficacy of Osimertinib for brain metastasis from EGFR-mutant lung cancer
Presenter: Lijuan Chen
Session: Poster Display session 1
Resources:
Abstract
4942 - Response assessment of melanoma brain metastases treated by stereotactic radiotherapy or immunotherapy or both: a comparison of RECIST 1.1, RANO and iRANO criteria
Presenter: Emilie Le Rhun
Session: Poster Display session 1
Resources:
Abstract
3529 - Management of multiple brain metastases by Staged SRS focusing on utmost risk lesions
Presenter: shaoqun Li
Session: Poster Display session 1
Resources:
Abstract
5315 - Whole brain radiotherapy plus simultaneous in-field boost versus whole brain radiotherapy plus fractionated stereotactic radiotherapy for multiple brain metastases of non-small cell lung cancer
Presenter: Lu Li
Session: Poster Display session 1
Resources:
Abstract
1116 - 3D based texture analysis serving as potential diagnostic factor in discriminating primary central nervous system lymphoma from metastatic brain tumors: A preliminary study
Presenter: Wen Guo
Session: Poster Display session 1
Resources:
Abstract