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Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial
Open accessAbstract
Background Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer.Methods We did this phase 2, single-arm trial at 27 sites (academic, hospital, and private cancer centres) in France, Germany, Italy, and USA. Patients who had received two or more previous treatments received intravenous nivolumab (3 mg/kg) every 2 weeks until progression or unacceptable toxic effects. The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee. We included all treated patients in the analyses. This study is registered with ClinicalTrials.gov, number NCT01721759.Findings Between Nov 16, 2012, and July 22, 2013, we enrolled and treated 117 patients. 17 (14·5%, 95% CI 8·7-22·2) of 117 patients had an objective response as assessed by an independent radiology review committee. Median time to response was 3·3 months (IQR 2·2-4·8), and median duration of response was not reached (95% CI 8·31-not applicable); 13 (77%) of 17 of responses were ongoing at the time of analysis. 30 (26%) of 117 patients had stable disease (median duration 6·0 months, 95% CI 4·7-10·9). 20 (17%) of 117 patients reported grade 3-4 treatment-related adverse events, including: fatigue (five [4%] of 117 patients), pneumonitis (four [3%]), and diarrhoea (three [3%]). There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease.Interpretation Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non-small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled, phase 3 studies of first-line and second-line treatment.Funding Bristol-Myers Squibb.
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“The expression of PD-L1 was neither prognostic nor predictive of clinical benefit in a retrospective analysis using various cut points in this study.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [97]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“A phase III trial (CheckMate 017) in patients previously treated for SCC compared 3 mg/kg of nivolumab given every 2 weeks with docetaxel, showing an improvement of 3.2 months [97,98]”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [97]
Experimental — accuracy not yet measuredIn the citing paper
“Nivolumab (BMS-936558, ONO-4538, or MDX1106, trade name Opdivo; Bristol-Myers Squibb, Princeton, NJ, USA) is a first-in-class fully human immunoglobulin G4 (IgG4) monoclonal antibody (mAb) inhibitor that suppresses PD-1 activity through selectively targeting and blocking the interaction between ligands (PD-L1 and PD-L2) and PD-1 receptor [35].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [35]
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Metadata
- Authors
- Rizvi, N. A., Mazières, J., Planchard, D., Stinchcombe, T. E., Dy, G. K., Antonia, S. J., Horn, L., Lena, H., Minenza, E., Mennecier, B., Otterson, G. A., Campos, L. T., Gandara, D. R., Levy, B. P., Nair, S. G., Zalcman, G., Wolf, J., Souquet, P.-J., Baldini, E., Cappuzzo, F., Chouaid, C., Dowlati, A., Sanborn, R., Lopez-Chavez, A., Grohe, C., Huber, R. M., Harbison, C. T., Baudelet, C., Lestini, B. J., & Ramalingam, S. S.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Centre Hospitalier Universitaire de Toulouse (FR)
- Institut Gustave Roussy (FR)
- University of North Carolina at Chapel Hill (US)
- Roswell Park Comprehensive Cancer Center (US)
- Moffitt Cancer Center (US)
- Vanderbilt University (US)
- Azienda Ospedaliera S.Maria (IT)
- Hôpital Civil, Strasbourg (FR)
- The Ohio State University Wexner Medical Center (US)
- UC Davis Comprehensive Cancer Center (US)
- Mount Sinai Beth Israel (US)
- Lehigh Valley Hospital (US)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- University Hospital Cologne (DE)
- Hospices Civils de Lyon (FR)
- Ospedale di Livorno (IT)
- University Hospitals of Cleveland (US)
- Providence Portland Medical Center (US)
- German Center for Lung Research (DE)
- Princeton University (US)
- Emory University (US)
- Corresponding author
- Rizvi, Naiyer A
- ORCID
- Rizvi, Naiyer A
- Mazières, Julien
- Planchard, David
- Stinchcombe, Thomas E
- Dy, Grace K
- Antonia, Scott J
- Horn, Leora
- Mennecier, Bertrand
- Otterson, Gregory A
- Campos, Luis T
- Gandara, David R
- Levy, Benjamin P
- Nair, Suresh G
- Zalcman, Gérard
- Wolf, Jürgen
- Cappuzzo, Federico
- Chouaid, Christos
- Dowlati, Afshin
- Sanborn, Rachel
- Huber, Rudolf M
- Ramalingam, Suresh S
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2015-03
- Volume
- 16
- Issue
- 3
- Pages
- 257-265
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC5726228
- OpenAlex
- W2106511606
- Cited by
- 1,415
- References
- 36
- Citations by year
- 2026: 23 · 2025: 35 · 2024: 62 · 2023: 84 · 2022: 81 · 2021: 114 · 2020: 128 · 2019: 135 · 2018: 179 · 2017: 228 · 2016: 229 · 2015: 111
- FWCI
- 108.74
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P30CA076292)
- 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
- PD-1 inhibitors, lung squamous cell carcinoma, refractory lung cancer, objective response rate, treatment safety, pneumonitis, immune-related adverse events, immune checkpoint blockade, non-relapse mortality, ischemic stroke, pneumonia, fatigue, diarrhea, previously treated patients, duration of response, stable disease, time to response
- MeSH terms
- Nivolumab, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Drug Administration Schedule, Europe, Female, Humans, Infusions, Intravenous, Lung Neoplasms, Male, Middle Aged, Risk Factors, Time Factors, United States, Signal Transduction, Comorbidity, Treatment Outcome, Disease Progression, Disease-Free Survival, Kaplan-Meier Estimate, Molecular Targeted Therapy, Programmed Cell Death 1 Receptor
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