Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer
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BACKGROUND: Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity. METHODS: In this randomized, open-label, international phase 3 study, we assigned patients with nonsquamous non-small-cell lung cancer (NSCLC) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival. RESULTS: Overall survival was longer with nivolumab than with docetaxel. The median overall survival was 12.2 months (95% confidence interval [CI], 9.7 to 15.0) among 292 patients in the nivolumab group and 9.4 months (95% CI, 8.1 to 10.7) among 290 patients in the docetaxel group (hazard ratio for death, 0.73; 96% CI, 0.59 to 0.89; P=0.002). At 1 year, the overall survival rate was 51% (95% CI, 45 to 56) with nivolumab versus 39% (95% CI, 33 to 45) with docetaxel. With additional follow-up, the overall survival rate at 18 months was 39% (95% CI, 34 to 45) with nivolumab versus 23% (95% CI, 19 to 28) with docetaxel. The response rate was 19% with nivolumab versus 12% with docetaxel (P=0.02). Although progression-free survival did not favor nivolumab over docetaxel (median, 2.3 months and 4.2 months, respectively), the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel (19% and 8%, respectively). Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression (≥1%, ≥5%, and ≥10%) of the PD-1 ligand. Treatment-related adverse events of grade 3 or 4 were reported in 10% of the patients in the nivolumab group, as compared with 54% of those in the docetaxel group. CONCLUSIONS: Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy, overall survival was longer with nivolumab than with docetaxel. (Funded by Bristol-Myers Squibb; CheckMate 057 ClinicalTrials.gov number, NCT01673867.).
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Nivolumab has significantly improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC).
“Nivolumab has significantly improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC); however, reliable prognostic biomarkers remain an unmet need.”
From SUVmax-IPI as a New Prognostic Index in Metastatic Non-Small Cell Lung Cancer Patients Receiving Nivolumab (2025) · cites this paper as [2]
The Abstract Results report significantly better overall survival and response rates with nivolumab than with docetaxel. The Methods (Patients) limit the trial to previously treated stage IIIB/IV or recurrent nonsquamous NSCLC, so the claim is broader than the population studied; progression-free survival also did not significantly improve. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn previously treated advanced NSCLC, PD-1/PD-L1 blockade improved overall survival compared with standard chemotherapy.
“Landmark trials performed on previously treated patients with advanced NSCLC demonstrated superior overall survival (OS) with PD-1/PD-L1 blockade compared to standard chemotherapy [1][2][3] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [3]
Immune checkpoint inhibitors targeting PD-1/PD-L1 have changed the treatment landscape for advanced non-small-cell lung cancer.
“The development of immune checkpoint inhibitors (ICI) targeting the PD-1/PD-L1 interaction has transformed the therapeutic landscape of patients with advanced non-small cell lung cancer (NSCLC) [1][2][3][4][5][6] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [3]
Inhibitors of programmed death 1 (PD-1) and its ligand PD-L1 are effective therapies for metastatic NSCLC lacking sensitising EGFR or ALK mutations.
“Inhibitors of programmed death 1 (PD-1) and its ligand PD-L1 are effective therapies for metastatic NSCLC lacking sensitising EGFR or ALK mutations.2–6”
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 [38]
Primary resistance to immune checkpoint inhibitors is common in patients with both RCC and NSCLC, ranging from 35% to 44%, and remains unpredictable.
“Primary resistance to ICI is common in patients with both RCC and NSCLC, ranging from 35% to 44% and remains unpredictable [1,3].”
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“Thus, synergism of TNF/TNFR1 de fi ciency and anti-PD-1 is likely not restricted to melanoma but applies to other cancers, such as lung carcinoma, which can bene fi t from anti-PD-1 according to phase 2 and phase 3 clinical trials 25,26 .”
- Authors
- Borghaei, H., Paz-Ares, L., Horn, L., Spigel, D. R., Steins, M., Ready, N. E., Chow, L. Q., Vokes, E. E., Felip, E., Holgado, E., Barlesi, F., Kohlhäufl, M., Arrieta, O., Burgio, M. A., Fayette, J., Lena, H., Poddubskaya, E., Gerber, D. E., Gettinger, S. N., Rudin, C. M., Rizvi, N., Crinò, L., Blumenschein, G. R., Antonia, S. J., Dorange, C., Harbison, C. T., Graf Finckenstein, F., & Brahmer, J. R.
- Affiliations
- Fox Chase Cancer Center (US)
- Hospital Universitario Virgen del Rocío (ES)
- Vanderbilt-Ingram Cancer Center (US)
- Sarah Cannon Research Institute (GB)
- University Hospital Heidelberg (DE)
- Duke Medical Center (US)
- University of Washington (US)
- University of Chicago (US)
- Vall d'Hebron Hospital Universitari (ES)
- Robert Bosch Hospital (DE)
- Instituto Nacional de Cancerología (MX)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Centre Léon Bérard (FR)
- Russian Cancer Research Center NN Blokhin (RU)
- The University of Texas Southwestern Medical Center (US)
- Yale Cancer Center (US)
- Memorial Sloan Kettering Cancer Center (US)
- Azienda Ospedaliera di Perugia (IT)
- Moffitt Cancer Center (US)
- Bristol-Myers Squibb (United States) (US)
- Sidney Kimmel Comprehensive Cancer Center (US)
- ORCID
- Borghaei, Hossein
- Paz-Ares, Luis
- Horn, Leora
- Spigel, David R.
- Ready, Neal E.
- Chow, Laura Q.
- Vokes, Everett E.
- Felip, Enriqueta
- Holgado, Esther
- Arrieta, Oscar
- Fayette, Jérôme
- Poddubskaya, Elena
- Gerber, David E.
- Gettinger, Scott N.
- Rudin, Charles M.
- Rizvi, Naiyer
- Blumenschein, George R.
- Antonia, Scott J.
- Brahmer, Julie R.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-10-22
- Volume
- 373
- Issue
- 17
- Pages
- 1627-1639
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5705936
- OpenAlex
- W2104347254
- Semantic Scholar
- 33144475f9fa050ec3e5c1fe259ffea415ad83c3
- Cited by
- 9,335
- References
- 22
- Citations by year
- 2026: 257 · 2025: 431 · 2024: 624 · 2023: 723 · 2022: 894 · 2021: 1091 · 2020: 1239 · 2019: 1123 · 2018: 1167 · 2017: 1033 · 2016: 686 · 2015: 41 · 2014: 3 · 2013: 3 · 2012: 1
- FWCI
- 426.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Bristol-Myers Squibb
- National Cancer Institute (P30CA008748)
- 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, docetaxel, non-squamous non-small cell lung cancer, PD-1 inhibitors, immune checkpoint inhibitors, overall survival, progression-free survival, response rate, treatment-emergent adverse events, immune-related adverse events, immune-related pneumonitis, immune-related colitis, immune-related endocrinopathy, immune-related dermatitis
- MeSH terms
- Docetaxel, Nivolumab, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Survival Analysis, Taxoids, B7-H1 Antigen
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