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Immunotherapy is often given for two years or until it stops working, but responses can last long after stopping. Trials that randomly assign responders to stop or continue would show whether the extra year is needed.
Non-inferiority trials randomising patients with response or stable disease after 12 months of PD-1/PD-L1 therapy to discontinuation with surveillance and retreatment at progression versus continuation to 24 months or beyond, with a 'treatment-free interval' and cumulative drug exposure as secondary endpoints. Several academic trials (e.g., in melanoma and NSCLC) are under way; the proposal is to make stop-versus-continue a standard post-approval requirement for durable-response agents.
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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.
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.
This study is why PD-1 inhibitors were developed across cancers rather than in melanoma alone: unexpected activity in lung cancer, historically thought immune-resistant, changed drug development priorities industry-wide. It also introduced PD-L1 immunohistochemistry as a candidate biomarker and pneumonitis as a signature toxicity. Within five years PD-1 blockade was approved in more than ten cancers.
Shares CheckMate 915, RELATIVITY-098, Fianlimab + cemiplimab phase 3 (first-line melanoma), CheckMate 227.
Shares CheckMate 915, RELATIVITY-098, Fianlimab + cemiplimab phase 3 (first-line melanoma), CheckMate 227.
Shares CheckMate 915, RELATIVITY-098, Fianlimab + cemiplimab phase 3 (first-line melanoma), CheckMate 227.
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, PD-1.
Shares Topalian 2012: the first large trial of a PD-1 antibody shows durable responses across melanoma, lung and kidney cancer, Nivolumab, PD-1, Melanoma.
Shares CheckMate 227, KEYNOTE-042, Prices and value, Nivolumab.