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http://purl.uniprot.org/citations/25399552http://www.w3.org/1999/02/22-rdf-syntax-ns#typehttp://purl.uniprot.org/core/Journal_Citation
http://purl.uniprot.org/citations/25399552http://www.w3.org/1999/02/22-rdf-syntax-ns#typehttp://purl.uniprot.org/core/Journal_Citation
http://purl.uniprot.org/citations/25399552http://www.w3.org/2000/01/rdf-schema#comment"

Background

Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study.

Methods

We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival.

Results

At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P<0.001). The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group (hazard ratio for death or progression of disease, 0.43; 95% CI, 0.34 to 0.56; P<0.001). The objective response rate was 40.0% (95% CI, 33.3 to 47.0) in the nivolumab group versus 13.9% (95% CI, 9.5 to 19.4) in the dacarbazine group (odds ratio, 4.06; P<0.001). The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups, including subgroups defined by status regarding the programmed death ligand 1 (PD-L1). Common adverse events associated with nivolumab included fatigue, pruritus, and nausea. Drug-related adverse events of grade 3 or 4 occurred in 11.7% of the patients treated with nivolumab and 17.6% of those treated with dacarbazine.

Conclusions

Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, NCT01721772.)."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.org/dc/terms/identifier"doi:10.1056/nejmoa1412082"xsd:string
http://purl.uniprot.org/citations/25399552http://purl.org/dc/terms/identifier"doi:10.1056/nejmoa1412082"xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Robert C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Robert C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Schmidt H."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Schmidt H."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Brady B."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Brady B."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Hassel J.C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Hassel J.C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Schadendorf D."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Schadendorf D."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Maio M."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Maio M."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Mauch C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Mauch C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Lebbe C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Lebbe C."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Mortier L."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Mortier L."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Atkinson V."xsd:string
http://purl.uniprot.org/citations/25399552http://purl.uniprot.org/core/author"Atkinson V."xsd:string
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