Follow-up trials for monoclonal anti-PD-1 antibody Cemiplimab (Libtayo) demonstrate a sustained and considerable antitumor activity and durable responses in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). Since receiving FDA approval in September (2018), the drug has completely changed skin cancer treatments.
In the United States, CSCC is the second most common form of skin malignancy, each year affecting more than 600.000 people according to estimates from the American Cancer Society. So far, Libtayo is the first and only treatment specifically designed to address this disease.
Most squamous cell carcinomas of the skin are a result of prolonged exposure to ultraviolet (UV) radiation, either from sunlight or from tanning beds or lamps.
The initial trial that lead to the approval had an overall response rate (ORR) of 47% with a median follow-up of 8.9 months, while updated figures show a consistent ORR of about 50% with durable disease control rates of 57.7%. Treatment-emergent adverse events (TEAEs) continue to be low to medium, most common being fatigue, arthralgia (joint pains), hypothyroidism, muscle weakness, and macular-papular rash.
Part of a new wave of immunotherapies, Cemiplimab targets the PD-1 (programmed cell death protein-1) checkpoint receptor which regulates the immune system. Patient cloned antibodies promote apoptosis, a natural process of renewing cells all throughout the body. On average, an adult loses between 50 and 70 billion cells each day due to apoptosis.
“We are proud to offer patients in the U.S. this first and only treatment for advanced CSCC and remain focused on advancing our clinical research investigating Libtayo as a potential monotherapy and combination therapy in other cancer types“, notes the press release.
As time goes on, it is expected for Libtayo to become standard treatment for cases of CSCC. The procedure has proven its effectiveness and continues to provide strong results.