KEYNOTE-426 (5-year update): reconstructed Kaplan–Meier curves
Pembrolizumab plus axitinib versus sunitinib for advanced clear cell renal cell carcinoma: 5-year survival and biomarker analyses of the phase 3 KEYNOTE-426 trial. Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | Nat Med. 2025 Aug 1;31(10):3475–84. doi: 10.1038/s41591-025-03867-5 |
|---|---|
| DOI | 10.1038/s41591-025-03867-5 |
| Registry | NCT02853331 |
| Phase | Phase 3 |
| Conditions | Renal Cell Carcinoma |
| Interventions | Pembrolizumab, Axitinib, Sunitinib |
| Sponsor | Merck Sharp & Dohme LLC |
| Enrolment | 861 |
| Source licence | Figure published under CC BY 4.0 |
Overall survival — Intention-to-treat population
From figure panel a · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Pembrolizumab plus axitinib 46.5 months; Sunitinib 41.4 months. Survival at 18 months: Pembrolizumab plus axitinib 81%; Sunitinib 72%. Hazard ratio Pembrolizumab plus axitinib vs Sunitinib 0.87 (95% CI 0.73–1.02).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab plus axitinib | 432 | 267 | 46.5 |
| Sunitinib | 429 | 279 | 41.4 |
- Pembrolizumab plus axitinib vs Sunitinib: reconstructed HR 0.87 (95% CI 0.73–1.02)
Landmark survival (reconstructed)
| Time | Pembrolizumab plus axitinib | Sunitinib |
|---|---|---|
| 6 mo | 98.1% | 89.2% |
| 12 mo | 90.9% | 79.5% |
| 18 mo | 80.6% | 72.0% |
| 24 mo | 74.4% | 65.6% |
| 36 mo | 62.4% | 54.0% |
| 48 mo | 48.9% | 45.2% |
| 60 mo | 41.7% | 37.3% |
Checks against the published figure
- Pembrolizumab plus axitinib median: printed 47.2, reconstructed 46.5 pass
- Sunitinib median: printed 40.8, reconstructed 41.4 pass
- Pembrolizumab plus axitinib events: printed 270, reconstructed 267 pass
- Pembrolizumab plus axitinib n: printed 432, reconstructed 432 pass
- Sunitinib events: printed 280, reconstructed 279 pass
- Sunitinib n: printed 429, reconstructed 429 pass
- hazard ratio: printed 0.84, reconstructed 0.867 pass
Progression-free survival — Intention-to-treat population
From figure panel b · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Pembrolizumab plus axitinib 15.7 months; Sunitinib 11.1 months. Survival at 18 months: Pembrolizumab plus axitinib 49%; Sunitinib 36%. Hazard ratio Pembrolizumab plus axitinib vs Sunitinib 0.69 (95% CI 0.58–0.80).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab plus axitinib | 432 | 306 | 15.7 |
| Sunitinib | 429 | 311 | 11.1 |
- Pembrolizumab plus axitinib vs Sunitinib: reconstructed HR 0.69 (95% CI 0.58–0.80)
Landmark survival (reconstructed)
| Time | Pembrolizumab plus axitinib | Sunitinib |
|---|---|---|
| 6 mo | 75.0% | 66.1% |
| 12 mo | 60.0% | 47.4% |
| 18 mo | 48.7% | 35.6% |
| 24 mo | 38.7% | 26.3% |
| 36 mo | 28.8% | 16.1% |
| 48 mo | 20.4% | 12.1% |
| 60 mo | 18.1% | 8.8% |
Checks against the published figure
- Pembrolizumab plus axitinib median: printed 15.7, reconstructed 15.7 pass
- Sunitinib median: printed 11.1, reconstructed 11.1 pass
- Pembrolizumab plus axitinib events: printed 306, reconstructed 306 pass
- Pembrolizumab plus axitinib n: printed 432, reconstructed 432 pass
- Sunitinib events: printed 311, reconstructed 311 pass
- Sunitinib n: printed 429, reconstructed 429 pass
- hazard ratio: printed 0.69, reconstructed 0.685 pass
Duration of response — Participants with a confirmed objective response
From figure panel e · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Pembrolizumab plus axitinib 23.4 months; Sunitinib 15.2 months. Survival at 18 months: Pembrolizumab plus axitinib 59%; Sunitinib 46%. Hazard ratio Pembrolizumab plus axitinib vs Sunitinib 0.72 (95% CI 0.56–0.91).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab plus axitinib | 262 | 167 | 23.4 |
| Sunitinib | 170 | 116 | 15.2 |
- Pembrolizumab plus axitinib vs Sunitinib: reconstructed HR 0.72 (95% CI 0.56–0.91)
Landmark survival (reconstructed)
| Time | Pembrolizumab plus axitinib | Sunitinib |
|---|---|---|
| 6 mo | 87.8% | 79.6% |
| 12 mo | 71.5% | 61.6% |
| 18 mo | 59.4% | 45.6% |
| 24 mo | 49.0% | 37.8% |
| 36 mo | 37.5% | 29.5% |
| 48 mo | 28.4% | 21.1% |
| 60 mo | 25.9% | 14.6% |
Checks against the published figure
- Pembrolizumab plus axitinib median: printed 23.6, reconstructed 23.4 pass
- Sunitinib median: printed 15.3, reconstructed 15.2 pass
About these data
Pseudo-IPD reproduces the published curves and numbers at risk; the rows are not real patients. Cite the publication (DOI above) and TrialCurve. The source figure is © the authors (CC BY 4.0); the charts here are redrawn from the reconstruction.
Load these data in R or Python
# R
library(survival)
d <- read.csv("https://trialcurve.com/data/trials/keynote-426-5-year-update-1.csv")
survfit(Surv(time, event) ~ arm, data = d)
coxph(Surv(time, event) ~ arm, data = d)
# Python
import pandas as pd
from lifelines import KaplanMeierFitter
d = pd.read_csv("https://trialcurve.com/data/trials/keynote-426-5-year-update-1.csv")
for arm, g in d.groupby("arm"):
KaplanMeierFitter().fit(g.time, g.event, label=arm).plot_survival_function()
Suggested citation: Nat Med. 2025 Aug 1;31(10):3475–84. doi: 10.1038/s41591-025-03867-5 doi:10.1038/s41591-025-03867-5. Reconstructed data: TrialCurve (2026), https://trialcurve.com/trials/keynote-426-5-year-update
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