The FDA has approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk for recurrence following surgery and radiation. This marks the first immunotherapy approved for this specific patient group and represents a major advancement for those facing the poorest outcomes. The approval introduces immunotherapy into the adjuvant setting, expanding treatment options for the second most common form of skin cancer.
Preventing Recurrence
“Until now, we lacked options to help prevent a devastating recurrence, and immunotherapy was only available for patients with advanced [cutaneous squamous cell carcinoma] who were no longer candidates for curative surgery or curative radiation,” explained Vishal A. Patel, MD, FAAD, director of cutaneous oncology and associate professor of dermatology at The George Washington University School of Medicine and Health Sciences. “Many patients who undergo surgical resection of their [CSCC] are later found, on full pathological evaluation, to be at high risk of recurrence.”
Dr. Patel noted that cemiplimab-rwlc, the first and only immunotherapy approved in the adjuvant setting, represents a practice-changing opportunity for this population, supported by data demonstrating a significant improvement in disease-free survival.
Delivering New Options
As dermatology increasingly embraces immunologically targeted therapies, treatments such as cemiplimab-rwlc are helping to close critical gaps for patients whose disease may return even after curative surgery and radiation.
A PD-1 inhibitor, cemiplimab-rwlc demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo in the pivotal phase 3 C-POST trial. This is the first immunotherapy approved for adjuvant use in CSCC and is expected to change the treatment paradigm, offering patients an effective, well-tolerated option earlier in their care journey.
Who’s at Risk?
- Individuals with fair skin, light hair, and light eyes are at higher risk, though CSCC also occurs in people with darker skin tones.
- Those with weakened immune systems, such as organ transplant recipients, are particularly vulnerable.
- While CSCC is most common in older adults — especially men — it is increasingly being diagnosed in younger individuals.
- A history of skin cancer, including basal cell carcinoma, increases the likelihood of developing CSCC.
Looking Ahead
The approval of cemiplimab-rwlc provides clinicians with a new evidence-based tool to help prevent recurrence in patients with high-risk CSCC. As immunotherapy continues to redefine the dermatologic oncology landscape, this milestone signals meaningful progress toward improving long-term outcomes and patient quality of life.
