CheckMate 649
The trial that added immunotherapy to first-line stomach cancer chemotherapy; at five years, 16% of patients with PD-L1-rich tumours were alive versus 6%.
Largest phase 3 in gastric cancer. PD-L1 CPS ≥5: OS 14.4 vs 11.1 months (HR 0.71), 5-year OS 16% vs 6% (Annals of Oncology 2026). All randomised: OS 13.7 vs 11.6 months (HR 0.79). FDA approved for all patients (2021); EMA and many guidelines restrict to CPS ≥5 because benefit in CPS <1 is unproven.
- Median 14.4 vs 11.1 months with Nivolumab + chemotherapy compared with Chemotherapy; about 3.3 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 29 percent lower chance of the event at any given time (hazard ratio 0.71, likely range 0.61 to 0.81).
- 16 vs 6 out of 100 alive at 5 years with Nivolumab + chemotherapy compared with Chemotherapy; 10 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- 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/oesophageal adenocarcinoma: nivolumab + chemotherapy vs 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.
1,581 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, PD-L1 CPS ≥5primary | Nivolumab + chemotherapy | 473 | 14.4 months | 0.71 (0.61–0.81) | — | link |
| Chemotherapy | 482 | 11.1 months | ||||
| Overall survival at 5 years, CPS ≥5 | Nivolumab + chemotherapy | — | 16 percent | — | — | link |
| Chemotherapy | — | 6 percent |
Pages like this
not linked directly; found by shared links- Key paperCheckMate 649: nivolumab plus chemotherapy as first treatment for advanced gastric, gastro-oesophageal junction and oesophageal adenocarcinoma
Shares Yelena Y. Janjigian, Combined positive score (CPS), PD-L1, Nivolumab.
- TrialSPOTLIGHT & GLOW
Shares CAPOX (capecitabine, oxaliplatin), Biomarker-directed first-line quadruplets in gastric cancer, FOLFOX (5-FU, leucovorin, oxaliplatin), Gastric & gastro-oesophageal junction cancer.
- TrialHERIZON-GEA-01
Shares Biomarker-directed first-line quadruplets in gastric cancer, Oesophageal cancer, PD-1, Gastric & gastro-oesophageal junction cancer.
- TrialKEYNOTE-590
Shares Combined positive score (CPS), Oesophageal cancer, PD-1.
- TrialKEYNOTE-859
Shares Combined positive score (CPS), PD-1, Gastric & gastro-oesophageal junction cancer.
- TrialCheckMate 577
Shares Nivolumab, Oesophageal cancer, PD-1, Gastric & gastro-oesophageal junction cancer.
- TrialKEYNOTE-048
Shares Combined positive score (CPS), PD-L1, PD-1.
- TrialCheckMate 648
Shares Nivolumab, Oesophageal cancer, PD-1.