Cemiplimab Continues to Show Strong Outcomes for Advanced Cutaneous Squamous Cell Carcinoma

FOR IMMEDIATE RELEASE

HEADLINE

Cemiplimab Continues to Show Strong Outcomes for Advanced Cutaneous Squamous Cell Carcinoma

SUMMARY

Cemiplimab, the first FDA-approved PD-1 inhibitor specifically indicated for advanced cutaneous squamous cell carcinoma (cSCC), continues to demonstrate high response rates and durable tumor control in ongoing clinical research. New York Mohs surgeon Dr. Dennis Porto highlights its importance as an option for patients with aggressive or unresectable disease.

BACKGROUND: CUTANEOUS SQUAMOUS CELL CARCINOMA AND HIGH-RISK CASES

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer. While most cases can be cured with surgery—especially Mohs micrographic surgery—certain tumors behave more aggressively. High-risk and advanced lesions may invade deeply, recur, or metastasize, requiring systemic therapy.

Before immunotherapy, options for locally advanced or metastatic cSCC were limited and often carried significant toxicity. The need for safe, effective systemic treatments for inoperable cases has been substantial.

NEW DEVELOPMENT: WHAT IS CEMIPLIMAB

Cemiplimab (brand name Libtayo) is a monoclonal antibody that targets the programmed death–1 (PD-1) receptor, restoring the immune system’s ability to recognize and destroy cancer cells. In 2018, the U.S. Food and Drug Administration approved cemiplimab for:

- metastatic cutaneous squamous cell carcinoma

- locally advanced cSCC not curable by surgery or radiation

Clinical trials have demonstrated:

- overall response rates approaching 50%

- complete responses in a subset of patients

- durable control with many responses lasting beyond one year

- a favorable safety profile compared with historic systemic treatments

Long-term extension studies continue to show impressive durability and improved survival metrics.

Cemiplimab is also being studied as:

- neoadjuvant therapy before surgery

- adjuvant therapy after high-risk tumor removal

- a component of combination immunotherapy regimens

These emerging indications may broaden its use in dermatologic oncology.

EXPERT COMMENTARY

“As a Mohs surgeon, I surgically remove skin cancer every day. Some SCCs are rather aggressive, and I'm always eager to see new and emerging therapies that could offer options or adjuncts. Cemiplimab is one that I am most excited about!” said Dr. Dennis Porto, MD, MPH, FAAD, a Mohs micrographic surgeon and dermatologist in New York City.

CLINICAL SIGNIFICANCE AND OUTLOOK

Cemiplimab has transformed the outlook for patients with advanced cSCC who cannot undergo surgery or radiation. For dermatologists and surgeons, it provides a crucial option in cases where tumors are too extensive, rapidly progressive, or medically complex for conventional management.

As neoadjuvant trial data mature, cemiplimab may also help shrink tumors before Mohs surgery or improve recurrence rates when used after high-risk excisions. This has potential to redefine multidisciplinary care for cSCC.

ABOUT DR. DENNIS PORTO

Dr. Dennis Porto, MD, MPH, FAAD, is a double board-certified Mohs micrographic surgeon and dermatologist practicing in New York City. He completed medical school at the University of Iowa, followed by a dermatology research fellowship at Harvard and advanced surgical training. Dr. Porto is a clinical assistant professor of dermatology at Mount Sinai and has published extensively in dermatologic surgery, skin-cancer management, and emerging oncologic therapies. His practice emphasizes evidence-based, patient-centered care integrating surgical excellence with innovative medical advances.