C-POST
Trial question
What is the effect of adjuvant cemiplimab therapy in patients at high risk for recurrence of cutaneous SCC?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 415
415 patients (67 female, 348 male).
Inclusion criteria: patients with local or regional cutaneous SCC at high risk for recurrence.
Key exclusion criteria: concurrent cancer; receipt of solid organ or stem cell transplant; clinically significant autoimmune disease; receipt of previous immunotherapy for cutaneous SCC.
Interventions
N=209 cemiplimab (intravenous dose of 350 mg every 3 weeks for 12 weeks followed by a dose increase to 700 mg administered every 6 weeks for up to 36 weeks).
N=206 placebo (matching placebo).
Primary outcome
Disease recurrence or death
24 events
65 events
65.0 events
48.8 events
32.5 events
16.3 events
0.0 events
Cemiplimab
Placebo
Significant
decrease ▼
Significant decrease in disease recurrence or death (24 events vs. 65 events; HR 0.32, 95% CI 0.2 to 0.51).
Secondary outcomes
Significant decrease in locoregional recurrence (9 events vs. 40 events; HR 0.2, 95% CI 0.09 to 0.4).
Significant decrease in distant recurrence (10 events vs. 26 events; HR 0.35, 95% CI 0.17 to 0.72).
No significant difference in overall survival at 2 years (94.8% vs. 92.3%; HR 1.16, 95% CI 0.53 to 2.56).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with local or regional cutaneous SCC at high risk for recurrence, cemiplimab was superior to placebo with respect to disease recurrence or death.
Reference
Danny Rischin, Sandro Porceddu, Fiona Day et al. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2025 May 31. Online ahead of print.
Open reference URL