WCLC 2019 – 5-year survival in advanced NSCLC: greater than 4-fold increase with nivolumab over docetaxel

  • Cristina Ferrario — Agenzia Zoe
  • Univadis
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  • In patients with previously treated non-small cell lung cancer (NSCLC), 5-years overall survival (OS) rates increased more than 4-fold after treatment with the PD-1 inhibitor nivolumab compared to docetaxel.
  •  No new safety signals emerged for nivolumab in the long-term and the drug remained well-tolerated.

Why this matters

  • Historically, survival outcomes for advanced NSCLC have been poor.
  • 5-years outcomes from CheckMate 017 and 057 represent the longest survival follow-up for randomized phase 3 trials of an immune checkpoint inhibitor in this population.  

Study design

  • CheckMate 017 and CheckMate 057 randomized phase 3 trials included patients with, respectively, squamous and non-squamous previously treated advanced NSCLC.
  • In the pooled analysis (CheckMate 017/057), 854 patients with ECOG performance status (PS) ≤ 1, progressing during or after first-line platinum-based chemotherapy were included.
  • Patients were randomized to nivolumab 3 mg/kg q2w or docetaxel 75 mg/m2 q3w until progression or unacceptable toxicity.
  • OS was the primary endpoint for the two studies; additional endpoints included progression-free survival (PFS), objective response rate (ORR), efficacy by tumour PD-L1 expression, safety, PROs.

Key results

  • Survival benefits were still evident for nivolumab vs docetaxel in the long-term pooled analysis, with 5-year OS rates 13.4% vs 2.6% (HR 0.68).
  • OS benefit with nivolumab vs docetaxel was observed across subgroups of patients.
  • The 5-years pooled PFS rate was 8% with nivolumab and 0% with docetaxel.
  • The chance of remaining progression-free at 5 years was 60% and 78% in patients without progression at 2 and 3 years, respectively, after treatment with nivolumab.
  • ORR was 19.7% for nivolumab and 11.2% for docetaxel.
  • At 5 years, 10% of survivors in nivolumab group were off study drug, progression-free and with no subsequent therapy vs 0% in the docetaxel group.
  • No evidence of grade 3-4 treatment-related adverse events (AE) and no new safety signals emerged for nivolumab with a minimum follow-up of 5 years.


  • Bristol-Myers Squibb.

Expert commentary

“It is interesting to note that, following platinum-based chemotherapy, nivolumab has shown survival benefits across all PD-L1 subsets, including the PD-L1 negative (