# KEYNOTE-426: pembrolizumab plus axitinib versus sunitinib for advanced renal cell carcinoma

Source: https://onco.cc/key-papers/paper-keynote-426-nejm-2019/  
OnCo record `paper-keynote-426-nejm-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Combining pembrolizumab with the kinase inhibitor axitinib lengthened survival and delayed progression compared with sunitinib as first treatment for advanced clear cell kidney cancer, across all risk groups.

## Summary

Phase 3 trial of 861 patients with previously untreated advanced clear cell renal cell carcinoma randomised to pembrolizumab plus axitinib or sunitinib.

At 12.8 months, overall survival at one year was 89.9 versus 78.3 percent (hazard ratio 0.53), median progression-free survival 15.1 versus 11.1 months and response 59.3 versus 35.7 percent; the final analysis confirmed a survival benefit (median 47.2 versus 40.8 months).

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2019
- DOI: 10.1056/NEJMoa1816714
- Authors: Rini BI, Plimack ER, Stus V, et al.
- Findings: One-year overall survival 89.9 percent vs 78.3 percent; hazard ratio 0.53 at first analysis.; Objective response 59.3 percent vs 35.7 percent.
- What it means: Immunotherapy plus a VEGF kinase inhibitor is a first-line standard for advanced clear cell kidney cancer in all risk groups; comparable regimens include nivolumab-cabozantinib and lenvatinib-pembrolizumab.
- Caveats: Open-label; the survival hazard ratio attenuated with longer follow-up (about 0.84).; Liver enzyme elevation is a characteristic combination toxicity.

## Sources

- N Engl J Med 2019: https://doi.org/10.1056/NEJMoa1816714
- PubMed: https://pubmed.ncbi.nlm.nih.gov/30779529/

## Connected records

- cancers: [Clear cell renal cell carcinoma](https://onco.cc/cancers/clear-cell-rcc/)
- drugs: [Axitinib](https://onco.cc/drugs/axitinib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Sunitinib](https://onco.cc/drugs/sunitinib/)
- trials: [KEYNOTE-426](https://onco.cc/trials/keynote-426/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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