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KEYNOTE-811 showed that adding the immunotherapy pembrolizumab to trastuzumab and chemotherapy shrank HER2-positive stomach cancers more often and kept them under control for longer, with the gain concentrated in tumours that also express PD-L1.
KEYNOTE-811 randomised 738 patients with previously untreated HER2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma to trastuzumab plus fluoropyrimidine and platinum chemotherapy with pembrolizumab or with placebo. The dual primary endpoints were progression-free and overall survival.
At the first interim analysis the pembrolizumab arm had a markedly higher objective response rate, which supported accelerated approval in the United States in May 2021. Later analyses showed longer progression-free survival, with the benefit concentrated in tumours with a PD-L1 combined positive score of 1 or more, and the indication was narrowed to that group in 2023. Overall survival results followed in the same direction in the PD-L1-positive population.
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.
738 enrolled.
Median follow-up 28.3 months
SourceMedian follow-up 38.4 months
SourceDid not meet prespecified significance criteria; continues to final analysis
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (second interim analysis)primary | Pembrolizumab + trastuzumab + chemotherapy | 350 | 10 months | 0.72 (0.6 to 0.87) | 0.0002 | link |
| Placebo + trastuzumab + chemotherapy | 348 | 8.1 months | ||||
| Overall survival (second interim analysis)primary | Pembrolizumab + trastuzumab + chemotherapy | 350 | 20 months | 0.87 (0.72 to 1.06) | 0.084 | link |
| Placebo + trastuzumab + chemotherapy | 348 | 16.9 months | ||||
| Progression-free survival (third interim analysis) | Pembrolizumab + trastuzumab + chemotherapy | 350 | 10 months | 0.73 (0.61 to 0.87) | - | link |
| Placebo + trastuzumab + chemotherapy | 348 | 8.1 months | ||||
| Overall survival (third interim analysis) | Pembrolizumab + trastuzumab + chemotherapy | 350 | 20 months | 0.84 (0.7 to 1.01) | - | link |
| Placebo + trastuzumab + chemotherapy | 348 | 16.8 months |
Shares Fluorouracil (5-FU), Merck & Co. (MSD), Capecitabine, Cisplatin and the tag subtype-trials.
Shares Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Cisplatin and the tag subtype-trials.
Shares Merck & Co. (MSD), Cisplatin, Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares HER2-positive gastric cancer, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares HER2-positive gastric cancer, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares HER2-positive gastric cancer, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.