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The trial behind sugemalimab's approval in China and later Europe, showing a PD-L1 antibody plus chemotherapy delays progression in both main types of lung cancer.
479 patients randomised 2:1. Median progression-free survival 7.8 versus 4.9 months (hazard ratio 0.50) at the interim analysis, with benefit in squamous and non-squamous histology and across PD-L1 levels; overall survival favoured sugemalimab at the final analysis. NMPA approval December 2021; European Commission approval July 2024, the first EU approval of a Chinese-developed PD-L1 antibody.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
A second publication from the GEMSTONE-302 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT03789604 with the most citations, so it is the natural first reading for anyone following the GEMSTONE-302 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Caicun Zhou, Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
Shares Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
Shares Non-small-cell lung cancer and the tag china.
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Shares Non-small-cell lung cancer and the tag china.
Shares Immune checkpoint inhibitors and the tag china.
Shares Immune checkpoint inhibitors and the tag china.
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