So far, the Phase 2 EMPOWER-CSCC-1 clinical study has evaluated cemiplimab (also known as Libtayo) in individuals with locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). Data from the first three groups has already been reported. According to OncLive, researchers recently presented data from Group 6 at the 2022 ESMO Congress. 

The first groups included in the study were designed to estimate and evaluate cemiplimab as a monotherapy for those with metastatic or unresectable locally advanced cSCC. In Group 6, researchers hoped to expand on the data that had already been collected. 

Altogether, 167 participants with cSCC enrolled in Group 6. These participants received 350mg intravenously administered cemiplimab one time every three weeks for up to 108 weeks (24.8 months). The study findings, published in Annals of Oncology, share that:

• The median progression-free survival rate for enrolled participants was 14.7 months. 
• Cemiplimab was found to be relatively effective. 9 evaluable participants (5.5%) achieved a complete response, while 65 evaluable participants (39.6%) achieved a partial response. 
• This therapy was found to be relatively safe and well-tolerated. However, nearly all evaluable patients experienced some form of side effect. The most common side effects included nausea, constipation or diarrhea, appetite loss, fatigue and general malaise, itchiness, muscle pain, and maculopapular rashes. 
• 23 patients discontinued treatment due to more severe adverse reactions. Additionally, adverse events caused death in 14 patients, though these were found to not be related to cemiplimab. Rather, the deaths were caused by various infections, gastrointestinal bleeds, or other similar health issues.

Ultimately, the data highlights cemiplimab as an effective therapeutic option for those with cSCC, especially those who cannot undergo radiation treatment. 

What is Cutaneous Squamous Cell Carcinoma (cSCC)? 

Known as the second most common form of skin cancer, cutaneous squamous cell carcinoma causes abnormal squamous cell growth in the skin’s middle and outer layers. cSCC may occur all over the body. However, it is more common in areas that have experienced high sun exposure. There are risk factors known to increase the risk of developing cSCC. These include fair skin, a weakened immune system, excessive sun exposure, tanning bed use, being older in age, smoking cigarettes, having a genetic disease like xeroderma pigmentosum, or having a history of sunburns, precancerous lesions, or skin cancer. The chance of developing cSCC also increases with age. 

Symptoms and signs related to cSCC can include:

• White or pale spots on the lips, gums, or cheeks
• A red, flat, and scaly area of skin that may crust or bleed
• Anal or genital sores
• A wound or sore that won’t heal 
• New sores which form on old scars
• An itchy, dry, scaly, or not-skin-colored bump 
• A growth that is higher than surrounding skin but has a depression in the middle
• Dry, pale, or cracked lesions on the lower lip that may burn when exposed to sun