TrialCurveKEYNOTE-048 (Japanese subgroup, 5-year): reconstructed Kaplan–Meier curves
First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE‑048. Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | Int J Clin Oncol. 2024 Oct 9;29(12):1825–39. doi: 10.1007/s10147-024-02632-x |
|---|---|
| DOI | 10.1007/s10147-024-02632-x |
| Registry | NCT02358031 |
| Phase | Phase 3 |
| Conditions | Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer |
| Interventions | Pembrolizumab, Cisplatin, Carboplatin, 5-FU, Cetuximab |
| Sponsor | Merck Sharp & Dohme LLC |
| Enrolment | 882 |
| Source licence | Figure published under CC BY 4.0 |
Overall survival — Japanese population, PD-L1 CPS ≥1 (pembrolizumab vs EXTREME, long-term follow-up)
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 22.4 months; EXTREME 15.6 months. Survival at 18 months: Pembrolizumab 56%; EXTREME 38%. Hazard ratio Pembrolizumab vs EXTREME 0.68 (95% CI 0.33–1.41).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab | 21 | 15 | 22.4 |
| EXTREME | 16 | 14 | 15.6 |
- Pembrolizumab vs EXTREME: reconstructed HR 0.68 (95% CI 0.33–1.41)
Landmark survival (reconstructed)
| Time | Pembrolizumab | EXTREME |
|---|---|---|
| 6 mo | 85.7% | 81.2% |
| 12 mo | 71.4% | 56.2% |
| 18 mo | 56.1% | 37.5% |
| 24 mo | 40.8% | 37.5% |
| 36 mo | 30.6% | 18.8% |
| 48 mo | 25.5% | 12.5% |
| 60 mo | 25.5% | 12.5% |
Checks against the published figure
- Pembrolizumab median: printed 22.6, reconstructed 22.4 pass
- EXTREME median: printed 15.8, reconstructed 15.6 pass
- Pembrolizumab events: printed 16, reconstructed 15 pass
- Pembrolizumab n: printed 21, reconstructed 21 pass
- EXTREME events: printed 14, reconstructed 14 pass
- EXTREME n: printed 16, reconstructed 16 pass
- hazard ratio: printed 0.7, reconstructed 0.681 pass
Progression-free survival (PFS) — Japanese population, PD-L1 CPS ≥1 (pembrolizumab vs EXTREME, long-term follow-up)
From figure panel B · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: Pembrolizumab 3.2 months; EXTREME 3.5 months. Survival at 18 months: Pembrolizumab 5%; EXTREME 6%. Hazard ratio EXTREME vs Pembrolizumab 0.95 (95% CI 0.48–1.86).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Pembrolizumab | 21 | 20 | 3.2 |
| EXTREME | 16 | 15 | 3.5 |
- EXTREME vs Pembrolizumab: reconstructed HR 0.95 (95% CI 0.48–1.86)
Landmark survival (reconstructed)
| Time | Pembrolizumab | EXTREME |
|---|---|---|
| 6 mo | 23.8% | 31.2% |
| 12 mo | 9.5% | 6.2% |
| 18 mo | 4.8% | 6.2% |
| 24 mo | 4.8% | 6.2% |
| 36 mo | 4.8% | 6.2% |
| 48 mo | 4.8% | 6.2% |
| 60 mo | 4.8% | 6.2% |
Checks against the published figure
- Pembrolizumab median: printed 3.3, reconstructed 3.2 pass
- EXTREME median: printed 3.5, reconstructed 3.5 pass
- Pembrolizumab events: printed 20, reconstructed 20 pass
- Pembrolizumab n: printed 21, reconstructed 21 pass
- EXTREME events: printed 15, reconstructed 15 pass
- EXTREME n: printed 16, reconstructed 16 pass
- hazard ratio: printed 1.04, reconstructed 1.05 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.
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