KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer
After chemotherapy had failed, pembrolizumab prolonged life compared with docetaxel in lung cancers expressing any PD-L1, with the largest gain in tumours where at least half the cells were positive, and caused fewer severe side effects.
Overview
KEYNOTE-010 randomised 1,034 patients with previously treated advanced non-small-cell lung cancer and a PD-L1 tumour proportion score of at least 1% to pembrolizumab at 2 mg/kg or 10 mg/kg or to docetaxel. Both pembrolizumab doses improved overall survival in the whole population and by a larger margin in the group with a score of 50% or more, with fewer grade 3 to 5 treatment-related adverse events than docetaxel. It secured pembrolizumab's regular approval in previously treated lung cancer and established PD-L1 of 1% as the entry threshold for that use.
- 1,034 patients with previously treated NSCLC and PD-L1 tumour proportion score of at least 1%; pembrolizumab 2 mg/kg, 10 mg/kg or docetaxel.
- Median overall survival 10.4 and 12.7 months with pembrolizumab vs 8.5 months with docetaxel; hazard ratios 0.71 and 0.61.
- In tumours with a score of 50% or more: median overall survival 14.9 and 17.3 vs 8.2 months; hazard ratios 0.54 and 0.50.
- Grade 3 to 5 treatment-related adverse events 13% and 16% vs 35%.
Alongside the CheckMate trials this study replaced docetaxel with PD-1 blockade as second-line treatment for most lung cancers, and its PD-L1 threshold of 1% became the basis of pembrolizumab's label in previously treated disease.
- Open-label design.
- Patients with PD-L1-negative tumours were excluded, so the trial says nothing about them.
- Second-line setting; first-line immunotherapy has since reduced its relevance.
Similar pages
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