Title: First-Line Nivolumab in Stage IV or Recurrent Non– Small-Cell Lung Cancer

Carbone, DP et al.


What You Need to Know:

When compared to chemotherapy, nivolumab did not significantly lengthen the time of progression-free survival but did produce a similar overall survival rate in patients with programmed death ligand 1 (PD-L1)–positive non–small-cell lung cancer (NSCLC).

Trial Design:

  • Open-label phase 3 trial compared the efficacy of nivolumab with platinum-based chemotherapy in patients with “untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more”
  • Patients were randomized (1:1) to receive 3 mg/kg of body weight of nivolumab administered intravenously once every 2 weeks or up to 6 cycles of platinum-based chemotherapy administered once every 3 weeks
  • Cross over to receive nivolumab occurred in chemotherapy-treated patients at the time of disease progression
  • Primary endpoint: progression-free survival (evaluated in patients with a PD-L1 expression level of ≥5%)

Key Outcomes:

  • 423 patients exhibited a PD-L1 expression of ≥5%
  • Median progression-free survival: 4.2 months for nivolumab patients vs 5.9 months for chemotherapy patients (HR for disease progression or death: 1.15; 95% CI: 0.91, 1.45; P=0.25)
  • Median overall survival: 14.4 months for nivolumab patients vs 13.2 months for chemotherapy patients (HR for death: 1.02; 95% CI: 0.80, 1.30)
  • 60% of chemotherapy patients (128/212) crossed over to receive nivolumab as subsequent therapy
  • Treatment-related adverse events of any grade: experienced by 71% of nivolumab patients vs 92% of chemotherapy patients
  • Treatment-related adverse events of grade 3 or 4: experienced by 18% of nivolumab patients vs 51% of chemotherapy patients