Libtayo (cemiplimab)
An investigational treatment for Adrenocortical Carcinoma.
The same compound appears under different names depending on the context. Here is how to identify Cemiplimab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Cemiplimab
- Brand name
- Libtayo
- Development code
- REGN2810
- Drug class
- Monoclonal antibody (anti-PD-1)
- Manufacturer
- Regeneron
- How it's taken
- Cemiplimab is given as an intravenous infusion over 30 minutes.
An immunotherapy given by IV infusion that removes a molecular brake on the immune system, allowing T cells to recognize and attack cancer cells. Being tested in advanced adrenocortical carcinoma.
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How Cemiplimab works
Cemiplimab is a checkpoint inhibitor that blocks the PD-1 protein on immune cells. Cancer cells often activate this checkpoint to hide from the immune system. By blocking PD-1, cemiplimab removes the 'off switch' that prevents immune cells from attacking, allowing the immune system to recognize and destroy cancer cells.
Mechanism: PD-1 immune checkpoint inhibitor that reactivates anti-tumor immunity
Side effects and safety
As an immunotherapy, cemiplimab can cause immune-related side effects including fatigue, rash, diarrhea, nausea, and muscle or joint pain. More serious effects like lung inflammation can occur but are relatively uncommon. Most side effects are manageable with supportive care.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Cemiplimab
Cemiplimab is given as an intravenous infusion over 30 minutes. In the adrenocortical carcinoma trial it is added to cabozantinib. Treatment continues until cancer progression or unacceptable side effects.
Clinical trial results
A National Cancer Institute-sponsored Phase 2 trial (NCT06900595) is comparing cabozantinib alone with cabozantinib plus cemiplimab in about 48 people aged 12 and older with advanced adrenocortical carcinoma. It began in 2026 and is recruiting, and its main measure is how long the cancer stays under control. A separate Phase 2 study in Italy (NCT07085572) is testing cemiplimab added to mitotane. Cemiplimab alone is already approved for cutaneous squamous cell carcinoma.
Main registered trial: NCT06900595 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
Cemiplimab (REGN2810) was developed by Regeneron Pharmaceuticals as a fully human monoclonal antibody against PD-1. First approved by the FDA in 2018 for advanced skin cancer, researchers are now exploring its potential in other cancers including adrenocortical carcinoma.
Explore Adrenocortical Carcinoma trials
Other Adrenocortical Carcinoma treatments
Common questions about Cemiplimab
▸What is Cemiplimab (Libtayo)?
An immunotherapy given by IV infusion that removes a molecular brake on the immune system, allowing T cells to recognize and attack cancer cells. Being tested in advanced adrenocortical carcinoma.
▸How does Cemiplimab work?
Cemiplimab is a checkpoint inhibitor that blocks the PD-1 protein on immune cells. Cancer cells often activate this checkpoint to hide from the immune system. By blocking PD-1, cemiplimab removes the 'off switch' that prevents immune cells from attacking, allowing the immune system to recognize and destroy cancer cells.
▸What are the side effects of Cemiplimab?
As an immunotherapy, cemiplimab can cause immune-related side effects including fatigue, rash, diarrhea, nausea, and muscle or joint pain. More serious effects like lung inflammation can occur but are relatively uncommon. Most side effects are manageable with supportive care.
▸How is Cemiplimab taken?
Cemiplimab is given as an intravenous infusion over 30 minutes. In the adrenocortical carcinoma trial it is added to cabozantinib. Treatment continues until cancer progression or unacceptable side effects.
▸Is Cemiplimab FDA approved?
Cemiplimab is currently in phase 2 clinical trials for Adrenocortical Carcinoma. It has not yet received FDA approval.
▸What is cemiplimab's primary approved indication?
Cemiplimab (Libtayo) was first approved by the FDA in 2018 for advanced cutaneous squamous cell carcinoma (skin cancer). Its use in adrenocortical carcinoma is investigational, being studied in Phase 2 trials.
▸How is cemiplimab being tested for adrenocortical carcinoma?
A National Cancer Institute-sponsored Phase 2 trial is testing whether adding cemiplimab to cabozantinib helps people with advanced adrenocortical carcinoma, compared with cabozantinib alone. A second Phase 2 study in Italy is testing cemiplimab added to mitotane.
▸How does cemiplimab work?
Cemiplimab blocks the PD-1 protein on immune cells, removing the off-switch that cancer cells exploit to avoid immune detection. This allows the immune system to recognize and destroy cancer cells.
▸What immune-related side effects can occur?
As an immunotherapy, cemiplimab can cause immune-related side effects including fatigue, rash, diarrhea, nausea, and muscle or joint pain. More serious effects like lung inflammation can occur but are relatively uncommon.
▸Who manufactures cemiplimab?
Cemiplimab (REGN2810) was developed by Regeneron Pharmaceuticals as a fully human monoclonal antibody against PD-1. It is marketed under the brand name Libtayo.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- ClinicalTrials.gov. Cabozantinib with or without cemiplimab in advanced adrenocortical carcinoma. https://clinicaltrials.gov/study/NCT06900595
- ClinicalTrials.gov. Cemiplimab plus mitotane in adrenocortical carcinoma. https://clinicaltrials.gov/study/NCT07085572