KEYNOTE-590
Added immunotherapy to first-line chemotherapy for all types of oesophageal cancer, with a survival benefit that held at five years.
OS 12.4 vs 9.8 months overall (HR 0.73); 13.9 vs 8.8 months in PD-L1 CPS ≥10 (HR 0.62). Five-year follow-up (ESMO Open 2025): OS HR 0.72. FDA approval March 2021 for all patients; EMA restricted to CPS ≥10. Benefit in PD-L1-negative disease is uncertain.
- Median 12.4 vs 9.8 months with Pembrolizumab + chemotherapy compared with Placebo + chemotherapy; about 2.6 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 27 percent lower chance of the event at any given time (hazard ratio 0.73).
- The treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- 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 advanced oesophageal cancer (squamous and adenocarcinoma) and Siewert I GEJ: pembrolizumab + cisplatin/5-FU vs chemotherapy. 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.
749 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, all patientsprimary | Pembrolizumab + chemotherapy | 373 | 12.4 months | 0.73 | — | link |
| Placebo + chemotherapy | 376 | 9.8 months | ||||
| Overall survival at 5-year follow-up | Pembrolizumab + chemotherapy | — | — | 0.72 (0.62–0.84) | — | link |
| Placebo + chemotherapy | — | — |
Pages like this
not linked directly; found by shared links- TrialKEYNOTE-859
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.
- TrialRATIONALE-306
Shares Oesophageal cancer, PD-1.
- TrialKEYNOTE-689
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-B96 / ENGOT-ov65
Shares Combined positive score (CPS), PD-1, Pembrolizumab.
- TrialKEYNOTE-355
- TrialCheckMate 648
Shares Oesophageal cancer, PD-1.