Study
| Phase 3, randomized, double-blind, international trial (C-POST) |
| Resected local or regional cutaneous squamous-cell carcinoma at high risk of recurrence |
| Cemiplimab (350 mg q3w ×12 wks → 700 mg q6w to 48 wks total) vs. Placebo |
Efficacy
| DFS @ 24 mos: 87.1% vs. 64.1% (cemiplimab vs. placebo) (HR: 0.32 [0.20–0.51]) |
| Freedom from locoregional recurrence @ 24 mos: 94.6% vs. 76.7% (HR: 0.20 [0.09–0.40]) |
| Freedom from distant recurrence @ 24 mos: 94.3% vs. 83.8% (HR: 0.35 [0.17–0.72]) |
| OS @ 2yrs: 94.8% vs. 92.3% |
Safety
| Grade ≥3 AEs: 23.9% vs. 14.2% |
| Immune-related AEs: 22.9% vs. 6.4% (grade ≥3: 7.3% vs. 0%) |
| Discontinuation due to AEs: 9.8% vs. 1.5% |
| Deaths due to AEs: 2 pts vs. 2 pts |
N Engl J Med. Published May 31, 2025
http://doi.org/10.1056/NEJMoa2502449
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
