CheckMate 017: nivolumab beats docetaxel in squamous lung cancer after chemotherapy
In squamous non-small-cell lung cancer that had progressed after platinum chemotherapy, the PD-1 antibody nivolumab prolonged life compared with docetaxel with far fewer severe side effects, regardless of PD-L1 status.
Overview
CheckMate 017 randomised 272 patients with advanced squamous non-small-cell lung cancer that had progressed during or after first-line platinum chemotherapy to nivolumab or docetaxel. Nivolumab improved overall survival, the primary endpoint, as well as response rate and progression-free survival, with a fraction of the grade 3 or 4 toxicity of docetaxel. Unlike its non-squamous companion trial CheckMate 057, the benefit did not depend on PD-L1 expression, which led to nivolumab's approval in squamous disease without a biomarker requirement.
- 272 patients with previously treated squamous NSCLC; nivolumab vs docetaxel.
- Median overall survival 9.2 vs 6.0 months, hazard ratio 0.59; one-year survival 42% vs 24%.
- Response rate 20% vs 9%; median progression-free survival 3.5 vs 2.8 months, hazard ratio 0.62.
- Grade 3 or 4 treatment-related adverse events 7% vs 55%; benefit was independent of PD-L1 expression.
With CheckMate 057 this trial ended docetaxel's role as the default second-line treatment in lung cancer and gave the first phase 3 proof that PD-1 blockade extends life in a common carcinoma. Its PD-L1-independent benefit in squamous disease still shapes how the biomarker is used.
- Open-label design.
- Second-line setting; first-line immunotherapy has since changed who reaches this point.
- Squamous histology only.
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