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Five-year outcomes from the randomized, phase III trials CheckMate 017 and 057: Nivolumab vs docetaxel in previously treated non–small-cell lung cancer

Journal of Clinical Oncology Jan 20, 2021

Borghaei H, Gettinger S, Vokes EE, et al. - Given that an improvement in overall survival (OS) as well as favorable safety was shown by nivolumab vs docetaxel in patients with previously treated, advanced squamous and nonsquamous non–small-cell lung cancer (NSCLC), respectively, in two phase 3 trials (CheckMate 017 and CheckMate 057), researchers here present 5-year pooled efficacy and safety outcomes from these trials. Using randomization, patients (N = 854; CheckMate 017/057 pooled) suffering from advanced NSCLC, with ECOG PS (Eastern Cooperative Oncology Group performance status) ≤ 1, and progression during or following first-line platinum-based chemotherapy were assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until progression or unacceptable toxicity. At 5 years, findings revealed that a survival benefit of nivolumab vs docetaxel persisted, with nivolumab showing a five-fold rise in OS rate and no new safety signals. For nivolumab vs docetaxel, 5-year pooled OS rates were 13.4% vs 2.6%, and 5-year PFS rates were 8.0% vs 0%, respectively.  These findings represent the first report of 5-year results from randomized phase 3 trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC.

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