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Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

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.

Author information

1
Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: nar2144@cumc.columbia.edu.
2
Hôpital Larrey, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
3
L'Institut Gustave Roussy, Villejuif, France.
4
University of North Carolina School of Medicine, Chapel Hill, NC, USA.
5
Roswell Park Cancer Institute, Buffalo, NY, USA.
6
H Lee Moffitt Cancer Center, Tampa, FL, USA.
7
Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
8
Centre Hospitalier Universitaire de Rennes, Rennes, France.
9
Ospedale S Maria, Terni, Italy.
10
Nouvel Hôpital Civil Chru de Strasbourg, Strasbourg, France.
11
The Ohio State University Medical Center, Columbus, OH, USA.
12
Oncology Consultants, PA, Houston, TX, USA.
13
University of California Davis Cancer Center, Sacramento, CA, USA.
14
Mount Sinai Beth Israel Comprehensive Cancer Center, New York, NY, USA.
15
Lehigh Valley Hospital, Allentown, PA, USA.
16
Centre Hospitalier Universitaire de Caen, Caen, France.
17
Universitaetsklinik Koeln, Koeln, Germany.
18
Hospices Civils de Lyon, Ch Lyon Sud, Pierre Benite, France.
19
Ospedale Campo Di Marte, Lucca, Italy.
20
Istituto Toscano Tumori, Livorno, Italy.
21
Chi De Creteil, Creteil, France.
22
University Hospitals of Cleveland, Cleveland, OH, USA.
23
Providence Portland Medical Center, Portland, OR, USA.
24
University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, USA.
25
Evangelische Lungenklinik Berlin, Berlin, Germany.
26
Klinikum der Universitaet Muenchen-Innenstadt, German Center for Lung Research, Munich, Germany.
27
Bristol-Myers Squibb, Princeton, NJ, USA.
28
Winship Cancer Institute, Emory University, Atlanta, GA, USA.

Abstract

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.

PMID:
25704439
DOI:
10.1016/S1470-2045(15)70054-9
[Indexed for MEDLINE]
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