This phase 3 study showed that adding pembrolizumab to weekly paclitaxel, with or without bevacizumab, significantly improved progression-free survival and overall survival in patients with platinum-resistant recurrent ovarian cancer. The benefit was observed in both PD-L1 positive and overall populations with a manageable safety profile consistent with known drug effects. These results establish pembrolizumab plus weekly paclitaxel as an effective new treatment option in this setting.
Study
|
Randomised, double-blind, placebo-controlled, phase 3 study [ENGOT-ov65/KEYNOTE-B96] |
| Platinum-resistant recurrent ovarian cancer with 1-2 previous systemic regimens |
| Pembrolizumab plus weekly paclitaxel vs placebo plus weekly paclitaxel; bevacizumab permitted
|
Efficacy
|
ORR in PD-L1 CPS >=1: 53% vs 47% |
| ORR overall: 50% vs 41% |
| mPFS in PD-L1 CPS >=1: 8.3 mos vs 7.2 mos (pembro + paclitaxel vs. placebo + paclitaxel) (HR 0.72 [0.58-0.89]) |
| mPFS overall: 8.3 mos vs 6.4 mos (HR 0.70 [0.58-0.84]) |
| mOS in PD-L1 CPS >=1: 18.2 mos vs 14.0 mos (HR 0.76 [0.61-0.94]) |
| mOS overall: 17.7 mos vs 14.0 mos (HR 0.82 [0.69-0.97])
|
Safety
|
Grade 3+ TRAEs: anaemia (12% vs. 8%), peripheral neuropathy (5% vs. 6%), fatigue (5% vs. 6%), neutropenia (14% vs. 14%) |
| Serious TRAEs: 33% vs 20% |
| Treatment-related AE leading to death: 1% vs 2% |
| Immune-mediated adverse events Grade 3+: 12% vs 3%
|
Lancet 2026;407:1525-1537
http://doi.org/10.1016/S0140-6736(26)00602-1
Reviewed by Ulas D. Bayraktar, MD on May 15, 2026
