TrialCurveKEYNOTE-045 (Japanese subgroup): reconstructed Kaplan–Meier curves
Pembrolizumab versus chemotherapy in recurrent, advanced urothelial cancer in Japanese patients: a subgroup analysis of the phase 3 KEYNOTE-045 trial. Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | Int J Clin Oncol. 2019 Nov 15;25(1):165–74. doi: 10.1007/s10147-019-01545-4 |
|---|---|
| DOI | 10.1007/s10147-019-01545-4 |
| Registry | NCT02256436 |
| Phase | Phase 3 |
| Conditions | Urothelial Cancer |
| Interventions | pembrolizumab, paclitaxel, vinflunine, docetaxel |
| Sponsor | Merck Sharp & Dohme LLC |
| Enrolment | 542 |
| Source licence | Figure published under CC BY 4.0 |
Overall survival — Japanese patients, ITT 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 7.6 months; Chemotherapy 8.3 months. Survival at 12 months: Pembrolizumab 40%; Chemotherapy 38%. Hazard ratio Pembrolizumab vs Chemotherapy 0.83 (95% CI 0.45–1.54).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab | 30 | 22 | 7.6 |
| Chemotherapy | 22 | 19 | 8.3 |
- Pembrolizumab vs Chemotherapy: reconstructed HR 0.83 (95% CI 0.45–1.54)
Landmark survival (reconstructed)
| Time | Pembrolizumab | Chemotherapy |
|---|---|---|
| 6 mo | 56.7% | 57.1% |
| 12 mo | 39.7% | 38.1% |
| 18 mo | 28.9% | 14.3% |
| 24 mo | 25.3% | 9.5% |
Checks against the published figure
- Pembrolizumab median: printed 7.9, reconstructed 7.6 pass
- Chemotherapy median: printed 8.3, reconstructed 8.28 pass
- Pembrolizumab events: printed 22, reconstructed 22 pass
- Pembrolizumab n: printed 30, reconstructed 30 pass
- Chemotherapy events: printed 19, reconstructed 19 pass
- Chemotherapy n: printed 22, reconstructed 22 pass
- hazard ratio (direction inferred): printed 0.81, reconstructed 0.834 pass
Progression-free survival — Japanese patients, ITT population
From figure panel b · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: Pembrolizumab 1.9 months; Chemotherapy 4.8 months. Survival at 12 months: Pembrolizumab 13%; Chemotherapy 24%. Hazard ratio Chemotherapy vs Pembrolizumab 0.58 (95% CI 0.32–1.04).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab | 30 | 27 | 1.9 |
| Chemotherapy | 22 | 20 | 4.8 |
- Chemotherapy vs Pembrolizumab: reconstructed HR 0.58 (95% CI 0.32–1.04)
Landmark survival (reconstructed)
| Time | Pembrolizumab | Chemotherapy |
|---|---|---|
| 6 mo | 20.0% | 38.3% |
| 12 mo | 13.3% | 23.9% |
| 18 mo | 10.0% | 4.8% |
| 24 mo | 10.0% | 4.8% |
Checks against the published figure
- Pembrolizumab median: printed 2, reconstructed 1.95 pass
- Chemotherapy median: printed 4.9, reconstructed 4.85 pass
- Pembrolizumab events: printed 27, reconstructed 27 pass
- Pembrolizumab n: printed 30, reconstructed 30 pass
- Chemotherapy events: printed 20, reconstructed 20 pass
- Chemotherapy n: printed 22, reconstructed 22 pass
- hazard ratio (direction inferred): printed 1.71, reconstructed 1.73 pass
Duration of response — Responders (CR or PR), Japanese patients, ITT population
From figure panel c · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Pembrolizumab 12.3 months; Chemotherapy 4.4 months. Survival at 6 months: Pembrolizumab 83%; Chemotherapy 25%. Hazard ratio Pembrolizumab vs Chemotherapy 0.43 (95% CI 0.08–2.26).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab | 6 | 3 | 12.3 |
| Chemotherapy | 4 | 3 | 4.4 |
- Pembrolizumab vs Chemotherapy: reconstructed HR 0.43 (95% CI 0.08–2.26)
Landmark survival (reconstructed)
| Time | Pembrolizumab | Chemotherapy |
|---|---|---|
| 6 mo | 83.3% | 25.0% |
| 12 mo | 66.7% | 25.0% |
| 18 mo | 50.0% | 25.0% |
Checks against the published figure
- Chemotherapy median: printed 4.4, reconstructed 4.37 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-045-japanese-subgroup-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-045-japanese-subgroup-1.csv")
for arm, g in d.groupby("arm"):
KaplanMeierFitter().fit(g.time, g.event, label=arm).plot_survival_function()
Suggested citation: Int J Clin Oncol. 2019 Nov 15;25(1):165–74. doi: 10.1007/s10147-019-01545-4 doi:10.1007/s10147-019-01545-4. Reconstructed data: TrialCurve (2026), https://trialcurve.com/trials/keynote-045-japanese-subgroup
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