# KEYNOTE-024 & KEYNOTE-189

Source: https://onco.cc/trials/keynote-024-189/  
OnCo record `keynote-024-189` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The two trials that made immunotherapy, alone or with chemotherapy, the first treatment for most advanced lung cancers.

## Summary

KEYNOTE-024 (305 patients, TPS ≥50%): 5-year OS 31.9% vs 16.3% with chemotherapy. KEYNOTE-189 (616 patients): 5-year OS 19.4% vs 11.3%. Together with KEYNOTE-407 (squamous) they define first-line care for driver-negative disease and are the control arms every new agent (ivonescimab, ADC combinations) must beat.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT02142738
- Phase: 3
- Setting: First-line metastatic NSCLC without EGFR/ALK: pembrolizumab alone (PD-L1 TPS ≥50%, KEYNOTE-024) or pembrolizumab + platinum-pemetrexed (any PD-L1, non-squamous, KEYNOTE-189)
- Sponsor: Merck
- Enrolled: 921
- Result: 5-year OS 31.9% vs 16.3% (024); 19.4% vs 11.3% (189).
- Outcomes: KEYNOTE-024: overall survival at 5 years, PD-L1 ≥50%: Pembrolizumab 31.9% vs Chemotherapy 16.3%, HR 0.62; KEYNOTE-189: overall survival, non-squamous: Pembrolizumab + chemotherapy 22 months vs Placebo + chemotherapy 10.6 months, HR 0.6
- Replication: Replicated by KEYNOTE-042 (PD-L1 ≥1%), KEYNOTE-407 (squamous), IMpower150, and CheckMate 227/9LA; the most replicated result in lung immunotherapy.

## Sources

- ClinicalTrials.gov NCT02142738: https://clinicaltrials.gov/study/NCT02142738
- ClinicalTrials.gov NCT02578680: https://clinicaltrials.gov/study/NCT02578680

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [KRAS G12C-mutant non-small-cell lung cancer](https://onco.cc/cancers/kras-g12c-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/)
- 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: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- terms: [Control arm and comparator (investigator's choice)](https://onco.cc/terms/control-arm/), [Landmark and milestone survival (5-year survival, median follow-up)](https://onco.cc/terms/landmark-survival/), [Tumour proportion score (TPS)](https://onco.cc/terms/tps/)
- people: [Martin Reck](https://onco.cc/people/martin-reck/)
- key papers: [Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50](https://onco.cc/key-papers/paper-keynote-024-189-j-clin-oncol-2021-update/), [KEYNOTE-024: pembrolizumab alone beats chemotherapy in PD-L1-high lung cancer](https://onco.cc/key-papers/paper-keynote-024-nejm-2016/)
- pairings: [PD-1 blockade + chemotherapy in PD-L1-low NSCLC](https://onco.cc/pairings/pd1-plus-chemo-pdl1-low/)
- trials: [CheckMate 026](https://onco.cc/trials/checkmate-026/), [IMpower110](https://onco.cc/trials/impower110/), [IMpower150](https://onco.cc/trials/impower150/), [KEYNOTE-010](https://onco.cc/trials/keynote-010/)
- bottlenecks: [No one can predict who responds to immunotherapy](https://onco.cc/bottlenecks/b-immunotherapy-response/)
- ideas: [Confirm ultra-low-dose immunotherapy so it can be afforded where most patients live](https://onco.cc/ideas/idea-tr1-low-dose-immunotherapy-for-lmic/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/)

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