KEYNOTE-859
Confirmed that adding a PD-1 blocker to first-line chemotherapy helps in stomach cancer, with the biggest gain in tumours rich in PD-L1.
OS HR 0.78 overall; CPS ≥1 OS 13.0 vs 11.4 months (HR 0.74); CPS ≥10 OS 15.7 vs 11.8 months (HR 0.65). FDA approval November 2023 for all PD-L1 levels; EMA restricted to CPS ≥1.
- Median 12.9 vs 11.5 months with Pembrolizumab + chemotherapy compared with Placebo + chemotherapy; about 1.4 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 22 percent lower chance of the event at any given time (hazard ratio 0.78, likely range 0.7 to 0.87).
- Median 15.7 vs 11.8 months with Pembrolizumab + chemotherapy compared with Placebo + chemotherapy; 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 35 percent lower chance of the event at any given time (hazard ratio 0.65, likely range 0.53 to 0.79).
- 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 HER2-negative advanced gastric/GEJ adenocarcinoma: pembrolizumab + chemotherapy vs placebo + chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); 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.
1,579 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, all randomisedprimary | Pembrolizumab + chemotherapy | 790 | 12.9 months | 0.78 (0.7–0.87) | — | link |
| Placebo + chemotherapy | 789 | 11.5 months | ||||
| Overall survival, CPS ≥10 | Pembrolizumab + chemotherapy | — | 15.7 months | 0.65 (0.53–0.79) | — | link |
| Placebo + chemotherapy | — | 11.8 months |
Pages like this
not linked directly; found by shared links- TrialKEYNOTE-590
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-826
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-048
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-689
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-B96 / ENGOT-ov65
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-355
- PersonYelena Y. Janjigian
Shares PD-1, Pembrolizumab, Gastric & gastro-oesophageal junction cancer.
- IdeaAn advance market commitment for PD-1 biosimilars for lower-income countries
Shares PD-1, Pembrolizumab.