First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer
Open accessAbstract
BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more. RESULTS: Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy. CONCLUSIONS: Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, NCT02041533 .).
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Inter- and intra-driver heterogeneity are also evident after PD-1 or PD-L1 inhibitor treatment, with only about 20% of unselected NSCLC patients deriving durable clinical benefit.
“Inter- and intra-driver heterogeneity are also evident following treatment with inhibitors of the immune checkpoint molecules PD-1 or PD-L1, with only ~20% of unselected NSCLC patients deriving durable clinical benefit38–43.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [39]
Other features such as tumor mutational burden appear to be associated with clinical benefit from PD-1/PD-L1 antibodies.
“other features such as TMB appear to also be associated with clinical benefit to PD-1 / PD-L1 antibodies”
From Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC (2018) · cites this paper as [28]
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“TMB assessment was conducted by the NGS-based FoundationOne CDx assay, which has since been approved by the US Food and Drug Administration as a companion diagnostic for targeted therapies, with indications in five solid tumors.23 The cost of NGS has dramatically decreased as a result of emerging technical advances; t…”
BackgroundMethodResultInfluentialSelf-citationRole of Immunotherapy in Triple-Negative Breast Cancer
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- Authors
- Carbone, D. P., Reck, M., Paz-Ares, L., Creelan, B., Horn, L., Steins, M., Felip, E., van den Heuvel, M. M., Ciuleanu, T.-E., Badin, F., Ready, N., Hiltermann, T. J. N., Nair, S., Juergens, R., Peters, S., Minenza, E., Wrangle, J. M., Rodriguez-Abreu, D., Borghaei, H., Blumenschein, G. R., Villaruz, L. C., Havel, L., Krejci, J., Corral Jaime, J., Chang, H., Geese, W. J., Bhagavatheeswaran, P., Chen, A. C., & Socinski, M. A.
- Affiliations
- Universidad Complutense de Madrid (ES)
- ORCID
- Carbone, David P.
- Reck, Martin
- Paz-Ares, Luis
- Horn, Leora
- Felip, Enriqueta
- Ciuleanu, Tudor-Eliade
- Badin, Firas
- Ready, Neal
- Hiltermann, T. Jeroen N.
- Nair, Suresh
- Juergens, Rosalyn
- Peters, Solange
- Wrangle, John M.
- Borghaei, Hossein
- Blumenschein, George R.
- Villaruz, Liza C.
- Havel, Libor
- Chang, Han
- Geese, William J.
- Socinski, Mark A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-06-22
- Volume
- 376
- Issue
- 25
- Pages
- 2415-2426
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6487310
- OpenAlex
- W2635951006
- Cited by
- 2,503
- References
- 20
- Citations by year
- 2026: 54 · 2025: 121 · 2024: 196 · 2023: 223 · 2022: 328 · 2021: 380 · 2020: 432 · 2019: 372 · 2018: 334 · 2017: 61
- FWCI
- 144.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- SERVAL (Université de Lausanne) (publishedVersion, other-oa)
- PubMed Central (acceptedVersion)
- QUT ePrints (Queensland University of Technology) (submittedVersion)
- IRIS (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- Lirias (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Radboud Repository (Radboud University) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- National Cancer Institute (UG1CA233259, K12CA157688, P30CA016672, P30CA016058)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nivolumab, non-small cell lung cancer, PD-L1 expression, first-line therapy, stage IV NSCLC, recurrent NSCLC, platinum-based chemotherapy, docetaxel, progression-free survival, overall survival, immune checkpoint inhibitors, treatment-related adverse events, PD-1 inhibitors, PD-L1 inhibitors, PD-1/PD-L1 blockade
- MeSH terms
- Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Disease-Free Survival, B7-H1 Antigen
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