CheckMate 057: nivolumab beats docetaxel after chemotherapy in non-squamous lung cancer
After platinum chemotherapy had failed, the PD-1 antibody nivolumab prolonged life compared with docetaxel in non-squamous lung cancer with far fewer severe side effects, and the benefit was largest in tumours expressing PD-L1.
Overview
CheckMate 057 randomised 582 patients with non-squamous non-small-cell lung cancer that had progressed during or after platinum-based chemotherapy to nivolumab or docetaxel. Nivolumab improved overall survival, the primary endpoint, with a higher response rate, longer duration of response and a fraction of the severe toxicity of docetaxel. Unlike its squamous counterpart CheckMate 017, the benefit depended on PD-L1 expression, with little difference in PD-L1-negative tumours, which fuelled the debate about PD-L1 as a biomarker.
- 582 patients with previously treated non-squamous NSCLC; nivolumab vs docetaxel.
- Median overall survival 12.2 vs 9.4 months, hazard ratio 0.73.
- Response rate 19% vs 12%; median duration of response 17.2 vs 5.6 months.
- Grade 3 or 4 treatment-related adverse events 10% vs 54%.
- Survival benefit increased with PD-L1 expression and was not evident in PD-L1-negative tumours.
With CheckMate 017 in squamous disease, this trial ended docetaxel's reign as the default second-line treatment for lung cancer and established PD-1 blockade as standard after chemotherapy. Its PD-L1 finding shaped how later first-line trials were designed and how the biomarker is used in the clinic.
- Open-label design.
- Early crossing of the survival curves suggested some patients fared worse on nivolumab in the first months.
- PD-L1 was assessed retrospectively on archival tissue.
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