# KEYNOTE-426

Source: https://onco.cc/trials/keynote-426/  
OnCo record `keynote-426` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first immunotherapy plus targeted-pill combination for kidney cancer, improving survival across all risk groups.

## Summary

KEYNOTE-426, trial NCT02853331 sponsored by Merck and reported in 2019, produced the first immunotherapy plus targeted tablet combination for kidney cancer, improving survival across all risk groups. It randomised 861 patients with untreated advanced clear-cell renal cell carcinoma to pembrolizumab plus axitinib or sunitinib, met its primary overall and progression-free survival endpoints, and led to FDA approval in April 2019, although the survival advantage attenuated over five years as control patients crossed over to later-line immunotherapy. OnCo links it to renal cell carcinoma, pembrolizumab, axitinib, sunitinib, the IMDC risk group term, Thomas Powles, Brian I. Rini and Jae Lyun Lee. Whether the shrinking long-term difference means the combination mainly brings immunotherapy forward rather than adding to it is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02853331
- Phase: 3
- Setting: Untreated advanced clear-cell RCC: pembrolizumab + axitinib vs sunitinib
- Sponsor: Merck
- Enrolled: 861
- Result: OS HR 0.84 final (47.2 vs 40.8 months); PFS HR 0.69.
- Outcomes: Overall survival (final, 5-year): Pembrolizumab + axitinib 47.2 months vs Sunitinib 40.8 months, HR 0.84; Progression-free survival: Pembrolizumab + axitinib 15.7 months vs Sunitinib 11.1 months, HR 0.69
- Replication: Consistent with JAVELIN Renal 101 (avelumab + axitinib, PFS only), CheckMate 9ER, and CLEAR.

## Sources

- ClinicalTrials.gov NCT02853331: https://clinicaltrials.gov/study/NCT02853331

## Connected records

- cancers: [Clear cell renal cell carcinoma](https://onco.cc/cancers/clear-cell-rcc/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Axitinib](https://onco.cc/drugs/axitinib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Sunitinib](https://onco.cc/drugs/sunitinib/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- people: [Brian I. Rini](https://onco.cc/people/brian-rini/), [Jae Lyun Lee](https://onco.cc/people/lee-jae-lyun/), [Thomas Powles](https://onco.cc/people/thomas-powles/)
- terms: [IMDC risk groups (favourable / intermediate / poor)](https://onco.cc/terms/imdc-risk/)
- key papers: [KEYNOTE-426: pembrolizumab plus axitinib versus sunitinib for advanced renal cell carcinoma](https://onco.cc/key-papers/paper-keynote-426-nejm-2019/)

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