A comprehensive meta-analysis of cemiplimab for advanced cutaneous squamous cell carcinoma may have demonstrated encouraging response rates and a manageable safety profile, according to the research.
In the systematic review, published in the Journal of Investigative Dermatology, investigators analyzed data from 19 studies encompassing 1,318 patients with advanced cutaneous squamous cell carcinoma (cSCC), representing the largest data set on cemiplimab outcomes to date. The median age of the patients was 76 years (range = 62.5–86.9), with 74.2% being male and 71.7% having primary tumors in the head and neck region.
Cemiplimab, an anti–PD-1 monoclonal antibody, showed a pooled objective response rate of 54.5% (95% confidence interval [CI] = 48.5%–60.3%), comprising a 21.3% complete response rate (95% CI = 16.3%–27.3%) and a 35.8% partial response rate (95% CI = 30.8%–41.3%). The overall disease control rate was 70.6% (95% CI = 64.7%–75.9%), indicating that most of the patients experienced at least some degree of tumor stabilization or shrinkage.
"Our meta-analysis highlights the efficacy of cemiplimab in treating advanced cSCC, as evidenced by substantial response and disease control rates," the study authors stated.
Survival rates were also analyzed, with 1-year overall survival at 62% (95% CI = 48%–75%) and 2-year overall survival at 42.8% (95% CI = 30%–57%). Disease-free survival rates at 1 and 2 years were 43.5% (95% CI = 33%–55%) and 29.8% (95% CI = 19%–44%), respectively.
The most common grade 1 and 2 adverse events included fatigue (19.3%), dermatitis (12.8%), anemia (13.0%), and thyroiditis (9.3%). Grade ≥ 3 events occurred less frequently, with fatigue (3.5%), anemia (3.6%), pneumonitis (2.8%), and dermatitis (3.0%) being the most common serious toxicities.
An age-related finding emerged through multivariate meta-regression analysis, with older age significantly associated with progressive disease (coefficient estimate = 0.08, 95% CI = 0.01–0.14, P = .02). This finding demonstrated that older age may be associated with an increased risk of disease progression in patients receiving cemiplimab.
The investigators compared cemiplimab's performance with other anti–PD-1 therapies for cSCC. Pembrolizumab, evaluated in the phase II KEYNOTE 629 trial (n = 105), showed a lower overall response rate of 34%, with complete and partial response rates of 4% and 31%, respectively.
"Overall, cemiplimab represents a valuable addition to the therapeutic armamentarium for advanced cSCC, offering significant clinical benefit with a manageable safety profile," the study authors underscored. They emphasized the need for further research to refine patient selection criteria and optimize treatment strategies, suggesting future studies should directly compare different PD-1 inhibitors to evaluate relative benefits.
The study, conducted by nivestigators primarily from the Department of Otolaryngology–Head and Neck Surgery at Louisiana State University Health Sciences Center, is scheduled to appear in the Journal of Investigative Dermatology.
The authors declared having no competing interests.