2017
DOI: 10.1056/nejmoa1613493
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First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer

Abstract: 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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Cited by 2,153 publications
(1,366 citation statements)
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“…As with other cancer therapies, patient selection remains a challenging area in defining appropriate efficacy endpoints for participants in IO trials as multifaceted clinical (e.g., smoking status in non–small cell lung cancer) and biomarker (e.g., PD-L1 status, mutation burden, gene expression) characteristics appear to affect the likelihood of response. This issue was illustrated in a recent phase III study in the first-line treatment of NSCLC, which randomly assigned patients with PD-L1–positive NSCLC to either platinum doublet chemotherapy or nivolumab (22). Despite stratifying patients by PD-L1 expression level and histology, retrospective analyses suggest that there may have been an imbalance in tumor mutation burden between the treatment arms which may have contributed to a lack of PFS or OS benefit for nivolumab over chemotherapy in this trial (22).…”
Section: Traditional Endpointsmentioning
confidence: 99%
“…As with other cancer therapies, patient selection remains a challenging area in defining appropriate efficacy endpoints for participants in IO trials as multifaceted clinical (e.g., smoking status in non–small cell lung cancer) and biomarker (e.g., PD-L1 status, mutation burden, gene expression) characteristics appear to affect the likelihood of response. This issue was illustrated in a recent phase III study in the first-line treatment of NSCLC, which randomly assigned patients with PD-L1–positive NSCLC to either platinum doublet chemotherapy or nivolumab (22). Despite stratifying patients by PD-L1 expression level and histology, retrospective analyses suggest that there may have been an imbalance in tumor mutation burden between the treatment arms which may have contributed to a lack of PFS or OS benefit for nivolumab over chemotherapy in this trial (22).…”
Section: Traditional Endpointsmentioning
confidence: 99%
“…IPF is significantly associated with patient characteristics, such as microsatellite instability and smoking history 7, 8, 9. Such characteristics are also associated with a high tumor mutation burden (TMB), a likely independent biomarker for ICI treatment in NSCLC 10. Although no information regarding TMB in NSCLC with IPF is currently available, a high PD‐L1 expression level and substantial TMB might account for the durable response of the proband to nivolumab.…”
Section: Discussionmentioning
confidence: 99%
“…PFS was found higher in the chemotherapy arm (4.2 versus 5.9 months). OS was found similar in both treatment arms (14.4 vs. 13.2 months) (44). In the squamous cell lung can- cer, nivolumab, a PD-1 antibody efficiency was compared with docetaxel in Checkmate 017.…”
Section: Immunotherapymentioning
confidence: 93%