# KEYNOTE-B96 / ENGOT-ov65

Source: https://onco.cc/trials/keynote-b96/  
OnCo record `keynote-b96` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05116189
- Phase: 3
- Setting: Platinum-resistant recurrent ovarian cancer, 1-2 prior lines: pembrolizumab + weekly paclitaxel ± bevacizumab vs placebo + paclitaxel ± bevacizumab
- Sponsor: Merck
- Result: OS 18.2 vs 14.0 months in CPS ≥1 (HR 0.76); ITT OS HR 0.82.
- Outcomes: Progression-free survival (CPS ≥1): Pembrolizumab + paclitaxel ± bev 8.3 months vs Placebo + paclitaxel ± bev 7.2 months, HR 0.72; Overall survival (CPS ≥1): Pembrolizumab + paclitaxel ± bev 18.2 months vs Placebo + paclitaxel ± bev 14 months, HR 0.76; Overall survival (all patients): Pembrolizumab + paclitaxel ± bev 17.7 months vs Placebo + paclitaxel ± bev 14 months, HR 0.82
- Replication: First positive phase 3; earlier trials (JAVELIN Ovarian 200, IMagyn050, DUO-O) were negative for OS.

## Sources

- ClinicalTrials.gov NCT05116189: https://clinicaltrials.gov/study/NCT05116189
- FDA approval, ASCO Post: https://ascopost.com/issues/february-25-2026/fda-approves-pembrolizumab-with-paclitaxel-for-platinum-resistant-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma/

## Connected records

- collections: [The ASCO Post](https://onco.cc/collections/src-asco-post/)
- cancers: [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-resistant ovarian cancer](https://onco.cc/cancers/platinum-resistant-ovarian-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PD-L1](https://onco.cc/targets/pdl1/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/)
- pairings: [Caution: checkpoint inhibitors in first-line ovarian cancer](https://onco.cc/pairings/caution-pd1-first-line-ovarian/)

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