ORIENT-11
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.
Overview
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.
- Median 8.9 vs 5 months with Sintilimab + pemetrexed-platinum compared with Placebo + pemetrexed-platinum; about 3.9 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 52 percent lower chance of the event at any given time (hazard ratio 0.482).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: First-line non-squamous NSCLC without EGFR or ALK alterations, China: sintilimab or placebo plus pemetrexed and platinum. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); the result should not be assumed for people whose cancer does not have it.
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.
Pages like this
not linked directly; found by shared links- TrialORIENT-16
Shares Innovent Biologics, Sintilimab, Immune checkpoint inhibitors and the tag china.
- TrialORIENT-32
Shares Innovent Biologics, Sintilimab, Immune checkpoint inhibitors and the tag china.
- PersonMichael Yu (Yu De-Chao)
Shares Innovent Biologics, Sintilimab and the tag china.
- TrialCameL
Shares Pemetrexed, Immune checkpoint inhibitors, Non-small-cell lung cancer and the tag china.
- CompanyGenFleet Therapeutics
Shares Innovent Biologics and the tag china.
- ProductFulzerasib
Shares Innovent Biologics, Non-small-cell lung cancer and the tag china.
- CompanyIASO Biotherapeutics
Shares Innovent Biologics and the tag china.
- PersonJianming Xu
Shares Sintilimab and the tag china.