KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer
In patients whose lung tumours carried PD-L1 on at least half their cells, pembrolizumab alone held the cancer back longer than chemotherapy and caused fewer serious side effects, making immunotherapy the first treatment for this group.
Overview
KEYNOTE-024 randomised 305 patients with untreated advanced non-small-cell lung cancer, a PD-L1 tumour proportion score of 50% or more and no EGFR or ALK alteration to pembrolizumab or platinum-based chemotherapy. Pembrolizumab improved progression-free survival, the primary endpoint, and overall survival at the interim analysis, with a higher response rate and fewer grade 3 to 5 adverse events, and patients on chemotherapy could cross over at progression. Five-year follow-up later confirmed the survival advantage. The trial made PD-L1 testing routine at lung cancer diagnosis and established chemotherapy-free first-line immunotherapy for the PD-L1-high group.
- 305 patients with PD-L1 tumour proportion score of 50% or more; pembrolizumab vs platinum doublet chemotherapy.
- Median progression-free survival 10.3 vs 6.0 months, hazard ratio 0.50.
- Overall survival hazard ratio 0.60 at the interim analysis; estimated six-month survival 80.2% vs 72.4%.
- Response rate 44.8% vs 27.8%; grade 3 to 5 treatment-related adverse events 26.6% vs 53.3%.
This trial is why PD-L1 is measured on every new advanced lung cancer and why a patient with a high score can start immunotherapy without chemotherapy. Together with KEYNOTE-189 for the rest of the population, it moved checkpoint inhibitors from second-line rescue to the first treatment most lung cancer patients receive.
- Applies only to the roughly 30% of patients with a PD-L1 score of 50% or more and no EGFR or ALK driver.
- Crossover from chemotherapy to pembrolizumab affected the survival comparison.
- PD-L1 testing varies by assay and is imperfect as a predictor within the eligible group.
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