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KEYNOTE-062 found that pembrolizumab on its own was no worse than chemotherapy for survival in PD-L1-positive stomach cancer, but adding it to chemotherapy did not clearly beat chemotherapy alone; the tumours with the most PD-L1, and those with mismatch-repair deficiency, gained the most.
KEYNOTE-062 randomised 763 patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (combined positive score of 1 or more) to pembrolizumab alone, pembrolizumab plus cisplatin and a fluoropyrimidine, or chemotherapy plus placebo. The primary endpoints were overall and progression-free survival in the PD-L1-positive and high-PD-L1 (score of 10 or more) populations.
Pembrolizumab alone was non-inferior to chemotherapy for overall survival, with a larger apparent advantage at a score of 10 or more, but pembrolizumab plus chemotherapy was not superior to chemotherapy alone. Patients with microsatellite-unstable tumours, a small subgroup, did strikingly well with pembrolizumab. The trial did not change first-line practice by itself, but its subgroup findings shaped how later chemo-immunotherapy trials and approvals were read.
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.
763 enrolled.
99.2% CI; median follow-up 29.4 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, PD-L1 CPS >=1 (non-inferiority)primary | Pembrolizumab | 256 | 10.6 months | 0.91 (0.69 to 1.18) | - | link |
| Chemotherapy | 250 | 11.1 months | ||||
| Overall survival, PD-L1 CPS >=10 | Pembrolizumab | - | 17.4 months | 0.69 (0.49 to 0.97) | - | link |
| Chemotherapy | - | 10.8 months | ||||
| Overall survival, PD-L1 CPS >=1primary | Pembrolizumab + chemotherapy | 257 | 12.5 months | 0.85 (0.7 to 1.03) | 0.05 | link |
| Chemotherapy | 250 | 11.1 months | ||||
| Progression-free survival, PD-L1 CPS >=1primary | Pembrolizumab + chemotherapy | 257 | 6.9 months | 0.84 (0.7 to 1.02) | 0.04 | link |
| Chemotherapy | 250 | 6.4 months |
Shares Fluorouracil (5-FU), Merck & Co. (MSD), Capecitabine, Cisplatin and the tag subtype-trials.
Shares PD-L1-high gastric cancer, Gastric & gastro-oesophageal junction cancer, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Cisplatin, Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Fluorouracil (5-FU), Capecitabine, Cisplatin, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Kohei Shitara, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Cisplatin, Immune checkpoint inhibitors and the tag subtype-trials.