ORIENT-16
The Chinese stomach cancer trial that showed adding sintilimab to chemotherapy helps patients live longer, especially when the tumour expresses PD-L1.
Overview
650 patients. Median overall survival 15.2 versus 12.3 months in all randomised patients (hazard ratio 0.77) and 18.4 versus 12.9 months in the PD-L1 CPS 5 or higher group (hazard ratio 0.66), published in JAMA in 2023. NMPA approval 2023. With CheckMate 649, KEYNOTE-859 and RATIONALE-305 it makes gastric cancer the disease where Chinese PD-1 trials most changed global practice.
- Median 15.2 vs 12.3 months with Sintilimab + CAPOX compared with Placebo + CAPOX; about 2.9 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 23 percent lower chance of the event at any given time (hazard ratio 0.77).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line unresectable gastric or gastro-oesophageal junction adenocarcinoma, China: sintilimab or placebo plus oxaliplatin and capecitabine. People in a different situation may not see the same effect.
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-11
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