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Adjuvant Cemiplimab for Cutaneous Squamous-Cell Carcinoma: Making the Case
Cutaneous squamous-cell carcinoma (cSCC) is a localized disease that can be cured surgically in most patients; however, about 5% develop nodal or distant metastases in association with more-aggressive disease. Now, Rischin and colleagues present data from C-POST, the first randomized trial of adjuvant immunotherapy with cemiplimab (which targets programmed death 1 [PD-1]) in patients with resected high-risk cSCC.
A total of 415 participants were assigned to receive either cemiplimab or placebo for up to 48 weeks with a median follow-up of 24 months. Patients were generally well matched for high-risk characteristics between groups. Regarding the primary endpoint of disease-free survival (DFS), the hazard ratio for recurrence or death was 0.32 — an indication of benefit for recipients of immunotherapy. Estimated DFS at 24 months' follow-up was 87% (cemiplimab) versus 64% (placebo). Toxicities were as expected for this class of drugs, with grade 3 adverse event rates reported as 24% (cemiplimab) and 14% (placebo).
Comment
This study makes a compelling case for adjuvant cemiplimab in the treatment of patients with resectable high-risk cSCC. While potentially practice changing, the findings are unsurprising given the high response rates (~50%) seen with anti–PD-1 agents in metastatic or unresectable cSCC. Moreover, a nonrandomized, phase 2 study demonstrated impressive activity for neoadjuvant cemiplimab with a pathologic complete response rate of 51%, further demonstrating immunotherapy's potent activity in this disease setting. Given the precedent seen in melanoma for the superiority of neoadjuvant anti–PD-1 therapy, one can imagine that neoadjuvant therapy will be afforded priority in the right patient population, with adjuvant therapy serving as a solid alternative approach — and with either option clearly superior to surgery alone.
Citation(s)
Author:
Rischin D et al.
Title:
Adjuvant cemiplimab or placebo in high-risk cutaneous squamous-cell carcinoma.
Source:
N Engl J Med
2025
May
31; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Margaret Callahan, MD, PhD