MedPath

Cemiplimab

Generic Name
Cemiplimab
Brand Names
Libtayo
Drug Type
Biotech
Chemical Formula
-
CAS Number
1801342-60-8
Unique Ingredient Identifier
6QVL057INT
Background

Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses.

Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.

Indication

Cemiplimab is indicated to treat:

Associated Conditions
Locally Advanced Basal Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Cervical Cancer, Metastatic Non-Small Cell Lung Cancer, Metastatic cutaneous squamous cell carcinoma, Recurrent Cervical Cancer, Metastatic Basal cell carcinoma
Associated Therapies
First Line Chemotherapy
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MAIA Biotechnology, Inc. Announces Expansion of Clinical Supply Agreement with ...

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MAIA Biotechnology Announces Expansion of Clinical Supply Agreement with Regeneron

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MAIA Biotech Expands Cancer Trial with Regeneron, Reports Promising NSCLC Results

MAIA Biotechnology expands 2021 clinical supply agreement with Regeneron for Phase 2 THIO-101 trial, evaluating THIO's efficacy with Libtayo® in third-line non-small cell lung cancer patients resistant to previous treatments. MAIA remains trial sponsor, with Regeneron supplying Libtayo®. Trial shows promising results in disease control, progression-free survival, and overall response rates. New patient enrollment planned, exploring potential accelerated approval in the U.S.
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MAIA Biotechnology Expands 2021 Clinical Supply Agreement with Regeneron for Phase 2 THIO-101 Trial

MAIA Biotechnology expands its 2021 clinical supply agreement with Regeneron for the Phase 2 THIO-101 trial, focusing on THIO's efficacy in third-line non-small cell lung cancer patients. The trial assesses THIO followed by cemiplimab (Libtayo®) for patients resistant to previous treatments. MAIA anticipates new patient enrollment soon and explores accelerated approval opportunities in the U.S.
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