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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.
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.
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.
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.
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.
Shares KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer, KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer, Objective response rate (ORR), Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch.
Shares KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer, KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer, PD-L1, Nivolumab.
Shares KEYNOTE-010 (Herbst 2016): pembrolizumab versus docetaxel in previously treated PD-L1-positive lung cancer, KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer, PD-L1, Nivolumab.
Shares Bristol Myers Squibb, Docetaxel, PD-L1, Nivolumab.
Shares Bristol Myers Squibb, Docetaxel, PD-L1, Nivolumab.
Shares Bristol Myers Squibb, Docetaxel, Nivolumab, Non-small-cell lung cancer.
Shares CheckMate 017: nivolumab beats docetaxel in squamous lung cancer after chemotherapy, Nivolumab, PD-1, Non-small-cell lung cancer.
Shares PD-L1, PD-1, Non-small-cell lung cancer.