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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.
KEYNOTE-859, trial NCT03675737 sponsored by Merck and reported in 2023, confirmed that adding the PD-1 antibody pembrolizumab to first-line chemotherapy helps in HER2-negative advanced gastric and gastro-oesophageal junction adenocarcinoma, with the biggest gain in tumours rich in PD-L1. It randomised 1,579 patients and met its primary overall survival endpoint in all randomised patients, with progressively larger effects at CPS 1 and CPS 10 or higher, leading to FDA approval in November 2023 for all PD-L1 levels while the EMA restricted it to CPS 1 or higher. OnCo links it to gastric cancer, PD-1 as a target, pembrolizumab, the CPS term and Sun Young Rha, and it replicates CheckMate 649. As with its predecessor, whether PD-L1-negative patients should receive immunotherapy is the open question the regional labels disagree on.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, all randomisedprimary | Pembrolizumab + chemotherapy | 790 | 12.9 months | 0.78 (0.7 to 0.87) | - | link |
| Placebo + chemotherapy | 789 | 11.5 months | ||||
| Overall survival, CPS ≥10 | Pembrolizumab + chemotherapy | - | 15.7 months | 0.65 (0.53 to 0.79) | - | link |
| Placebo + chemotherapy | - | 11.8 months |
Shares Microsatellite-unstable (MSI-high) gastric cancer, Merck & Co. (MSD), Gastric & gastro-oesophageal junction cancer, Pembrolizumab.
Shares Microsatellite-unstable (MSI-high) gastric cancer, PD-L1-high gastric cancer, Merck & Co. (MSD), Gastric & gastro-oesophageal junction cancer.
Shares Microsatellite-unstable (MSI-high) gastric cancer, PD-L1-high gastric cancer, Combined positive score (CPS), PD-1.
Shares Combined positive score (CPS), Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares Combined positive score (CPS), Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares PD-L1-high gastric cancer, Gastric & gastro-oesophageal junction cancer, Pembrolizumab, Immune checkpoint inhibitors.
Shares Sun Young Rha, Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares PD-L1-high gastric cancer, Gastric & gastro-oesophageal junction cancer, Immune checkpoint inhibitors.