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Immunotherapy antibodies stay active in the body for weeks, yet are often given every two or three weeks. After a few months, spacing doses out to every two or three months might work as well, with fewer hospital visits and much lower cost.
Non-inferiority trials randomising patients with response or stable disease after 3-6 months of PD-1/PD-L1 blockade to extended-interval dosing (e.g., every 8-12 weeks, PK-guided) versus standard intervals, with PFS or TTF non-inferiority and cumulative dose, cost and toxicity as secondaries. Receptor occupancy studies show saturation at exposures far below label; PK-guided interval extension has been piloted.
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 CheckMate 227, KEYNOTE-042, Wrong doses, Prices and value.
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.