Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy
2015; American Medical Association; Volume: 2; Issue: 1 Linguagem: Inglês
10.1001/jamaoncol.2015.3934
ISSN2374-2445
AutoresDickran Kazandjian, Sean Khozin, Gideon M. Blumenthal, Lijun Zhang, Shenghui Tang, Meredith Libeg, Paul G. Kluetz, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur,
Tópico(s)Cancer Genomics and Diagnostics
ResumoImportance Metastatic squamous non–small-cell lung cancer (SQ NSCLC) is a serious and life-threatening malignant condition with unmet medical need. In late December 2014, the US Food and Drug Administration (FDA) obtained the data monitoring committee report of a planned interim analysis of a trial in second-line SQ NSCLC (CM017) that demonstrated an overall survival benefit for patients treated with nivolumab compared with docetaxel. Observations In that trial, 272 patients with metastatic SQ NSCLC patients had been randomized to receive nivolumab (n = 135) or docetaxel (n = 137). Median overall survival was 9.2 months for patients randomized to nivolumab and 6.0 months for those randomized to docetaxel (hazard ratio, 0.59; 95% CI, 0.44-0.79; P < .001). The safety of nivolumab was evaluated in a single-arm trial of 117 patients in previously treated metastatic SQ NSCLC and was consistent with the safety profile in melanoma, with rare but serious immune-mediated adverse events managed with corticosteroids and dose interruption. Conclusions and Relevance The FDA granted nivolumab traditional approval on March 4, 2015, for treatment of metastatic SQ NSCLC with progression during or after platinum-based chemotherapy. The approval provides an important treatment option for these patients, affecting routine care and clinical trials.
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