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The trial that made sintilimab a first-line lung cancer treatment in China, and the one the FDA later refused to accept as evidence for US patients.
397 patients randomised 2:1. Median progression-free survival 8.9 versus 5.0 months (hazard ratio 0.482) at the interim analysis, with benefit across PD-L1 subgroups; overall survival later favoured sintilimab. NMPA approval followed in February 2021. Innovent and Lilly filed the same data with the FDA; at a February 2022 advisory committee members voted 14 to 1 that a single-country trial with a chemotherapy-alone comparator did not show applicability to US patients, and a complete response letter followed in March 2022, setting the template for how China-only trials are judged.
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 ORIENT-11 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 NCT03607539 with the most citations, so it is the natural first reading for anyone following the ORIENT-11 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 Innovent Biologics, Sintilimab, Immune checkpoint inhibitors and the tag china.
Shares Innovent Biologics, Sintilimab, Immune checkpoint inhibitors and the tag china.
Shares Innovent Biologics, Sintilimab and the tag china.
Shares Pemetrexed, Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
Shares National Medical Products Administration / Center for Drug Evaluation, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation and the tag china.
Shares Innovent Biologics and the tag china.
Shares Sintilimab and the tag china.
Shares National Medical Products Administration / Center for Drug Evaluation and the tag china.