# KEYNOTE-590

Source: https://onco.cc/trials/keynote-590/  
OnCo record `keynote-590` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Added immunotherapy to first-line chemotherapy for all types of oesophageal cancer, with a survival benefit that held at five years.

## Summary

KEYNOTE-590, trial NCT03189719 sponsored by Merck and reported in 2020, added pembrolizumab to first-line cisplatin and fluorouracil chemotherapy for all types of advanced oesophageal cancer and Siewert type I junction tumours, with a survival benefit that held at five years. It randomised 749 patients and met its primary overall survival endpoint in all patients, with a larger effect in PD-L1 CPS 10 or higher, and the five-year follow-up published in ESMO Open in 2025 confirmed the benefit; the FDA approved it for all patients in March 2021 while the EMA restricted it to CPS 10 or higher. OnCo links it to oesophageal cancer, PD-1 as a target, pembrolizumab, the CPS term and Ken Kato. Benefit in PD-L1-negative disease is uncertain, which is the open question behind the regional label split.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03189719
- Phase: 3
- Setting: First-line advanced oesophageal cancer (squamous and adenocarcinoma) and Siewert I GEJ: pembrolizumab + cisplatin/5-FU vs chemotherapy
- Sponsor: Merck
- Enrolled: 749
- Result: OS 12.4 vs 9.8 months (HR 0.73); 5-year OS HR 0.72.
- Outcomes: Overall survival, all patients: Pembrolizumab + chemotherapy 12.4 months vs Placebo + chemotherapy 9.8 months, HR 0.73; Overall survival at 5-year follow-up: Pembrolizumab + chemotherapy vs Placebo + chemotherapy, HR 0.72
- Replication: Replicated by CheckMate 648, RATIONALE-306, ESCORT-1st, JUPITER-06, and ORIENT-15 in squamous disease.

## Sources

- ClinicalTrials.gov NCT03189719: https://clinicaltrials.gov/study/NCT03189719

## Connected records

- cancers: [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [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/)
- people: [Ken Kato](https://onco.cc/people/ken-kato/)
- key papers: [KEYNOTE-590: pembrolizumab plus chemotherapy for first-line treatment of advanced oesophageal cancer](https://onco.cc/key-papers/paper-keynote-590-lancet-2021/)

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