Libtayo, a product of Regeneron Pharmaceuticals, has shown positive results in the treatment of those with advanced cutaneous squamous cell carcinoma. This data comes from a Phase 2 trial and was presented at the 2020 American Society of Clinical Oncology Annual Meeting, which was held virtually due to COVID-19.
About Squamous Cell Carcinoma
Squamous cell carcinoma is a form of skin cancer, affecting the middle and outer layers of the skin. It most commonly occurs in the areas of the body that see the most sun exposure. UV rays are the most common cause, with risk factors such as fair skin, many sunburns, tanning beds, a weak immune system, a history of skin cancer, and certain genetic conditions heightening the chance of this cancer.
Symptoms include red nodules, flat sores, sores inside of the mouth, sores appearing on top of scars, and sores on the anus and genitals. This cancer can spread and damage other healthy tissue, causing complications. Because of this, it is important to seek treatment.
A physical exam and skin biopsy will be used to obtain a diagnosis. Treatment consists of surgery to remove the carcinoma, laser therapy, photodynamic therapy, topical medications, and cryosurgery. If the carcinoma is larger, Mohs surgery, simple excisions, and radiation will be used. Cancer that has spread will be treated with chemotherapy, targeted therapy, and immunotherapy.
Prevention is possible. People can take steps to avoid excessive sun exposure and tanning beds. Wearing sunscreen and protective clothing is also another way to lower the risk of squamous cell carcinoma. Checking the skin regularly can also help with early diagnosis and treatment.
Libtayo is a monoclonal antibody that targets and binds to PD-1 on T-cells, which is an immune checkpoint receptor. Through binding, Libtayo prevents malignant cells from using these pathways and activating T-cells.
While this treatment is the only therapy for those with advanced cutaneous squamous cell carcinoma who are not eligible for curative radiation or surgery, it is also being investigated for the treatment of other cancers. Regeneron believes that Libtayo may be a viable option for “difficult-to-treat” cancers, such as advanced basal cell carcinoma, non-small cell lung cancer, and cervical cancer.
About the Trial Results
This trial was single-arm, open-label, global, and enrolled 193 participants. It also represents the most mature and largest study within the realm of advanced cutaneous squamous cell carcinoma. The results of the Phase 2 trial show the highest complete response (CR) rates, along with positive overall survival rates. Both of these statistics were found after three years of follow-up. Other results include:
- 46% of participants saw substantial tumor shrinkage within two months of treatment
- 16% of participants saw their tumors disappear completely
- Metastatic patients saw a 20% complete response, which is a 13% increase from a primary analysis conducted in 2o17
- The median time to CR was 11 months
- 91% of participants experienced an improved or stable health-related quality of life
- 43% saw a reduction in pain
There were no new safety issues; common adverse events included nausea, fatigue, and diarrhea. Medical professionals are very excited by these results, as they show that Libtayo is a viable treatment option and can be a standard of care for squamous cell carcinoma.
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