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After a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint-inhibitor approval in the disease.
KEYNOTE-B96, also ENGOT-ov65, trial NCT05116189 sponsored by Merck and published in the Lancet in 2026, was, after a decade of failures, the first immunotherapy trial to extend survival in ovarian cancer, leading to the first checkpoint inhibitor approval in the disease. It randomised women with platinum-resistant recurrent disease to pembrolizumab or placebo with weekly paclitaxel, with or without bevacizumab, met its primary progression-free survival endpoint and improved overall survival in PD-L1-positive tumours, with a smaller survival benefit overall, and FDA approval followed in February 2026 for PD-L1-positive disease, including the subcutaneous formulation. OnCo links it to ovarian cancer, PD-1 and PD-L1 as targets, pembrolizumab, paclitaxel, bevacizumab and the CPS term. Why immunotherapy works in resistant but not first-line disease is the open question.
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.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (CPS ≥1)primary | Pembrolizumab + paclitaxel ± bev | - | 8.3 months | 0.72 (0.58 to 0.89) | - | link |
| Placebo + paclitaxel ± bev | - | 7.2 months | ||||
| Overall survival (CPS ≥1) | Pembrolizumab + paclitaxel ± bev | - | 18.2 months | 0.76 (0.61 to 0.94) | - | link |
| Placebo + paclitaxel ± bev | - | 14 months | ||||
| Overall survival (all patients) | Pembrolizumab + paclitaxel ± bev | - | 17.7 months | 0.82 (0.69 to 0.97) | - | link |
| Placebo + paclitaxel ± bev | - | 14 months |
Shares Caution: checkpoint inhibitors in first-line ovarian cancer, PD-L1, Bevacizumab, Ovarian cancer.
Shares Combined positive score (CPS), Bevacizumab, Merck & Co. (MSD), Paclitaxel / nab-paclitaxel.
Shares Platinum-resistant ovarian cancer, Bevacizumab, Paclitaxel / nab-paclitaxel, Ovarian cancer.
Shares PD-L1, Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares Combined positive score (CPS), Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares Platinum-resistant ovarian cancer, Ovarian cancer, Pembrolizumab, Immune checkpoint inhibitors.
Shares Combined positive score (CPS), Merck & Co. (MSD), PD-1, Pembrolizumab.
Shares Platinum-resistant ovarian cancer, Paclitaxel / nab-paclitaxel, Ovarian cancer.