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
Odronextamab ASH Presentations Underscore Impressive Efficacy Across B-Cell Non-Hodgkin Lymphoma Subtypes
Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. It also demonstrated efficacy in DLBCL post-CAR-T therapy and high response rates in relapsed/refractory marginal zone lymphoma, highlighting its potential across B-cell non-Hodgkin lymphoma subtypes.
Regeneron's Odronextamab Shows Remarkable 100% Response Rate in Lymphoma
Odronextamab showed 100% complete response in untreated follicular lymphoma, 48% objective response in DLBCL post-CAR-T, and 77% complete response in relapsed/refractory marginal zone lymphoma. EU approval secured; U.S. resubmission planned for 2025.
Related Clinical Trials:
Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
Odronextamab showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed durable responses in DLBCL post-CAR-T therapy. ELM-2 trial demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
Odronextamab ASH Presentations Underscore Impressive Results in B-cell Non-Hodgkin Lymphoma Treatment
Odronextamab shows promising results in treating various B-cell non-Hodgkin lymphoma subtypes, including complete responses in untreated follicular lymphoma and durable responses in diffuse large B-cell lymphoma post CAR-T therapy. High complete response rates were also observed in relapsed/refractory marginal zone lymphoma. Safety profiles were manageable, with cytokine release syndrome being the most common adverse event.
Odronextamab ASH Presentations Underscore Impressive Outcomes in Lymphoma Trials
Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed durable responses in DLBCL post-CAR-T therapy. ELM-2 trial demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
Odronextamab ASH Presentations Underscore Impressive Outcomes
Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed durable responses in DLBCL post-CAR-T therapy, and ELM-2 demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
MAIA Biotechnology Announces Expansion of Clinical Supply Agreement with Regeneron
MAIA Biotechnology amends 2021 clinical supply agreement with Regeneron for THIO-101 Phase 2 trial expansion, aiming to assess THIO's efficacy in third-line non-small cell lung cancer patients resistant to previous treatments. New patient enrollment expected soon.
Related Clinical Trials:
MAIA Biotech expands phase 2 trial for lung cancer treatment
MAIA Biotechnology expands Phase 2 trial of THIO-101 to evaluate THIO in combination with Regeneron's Libtayo® for third-line NSCLC patients resistant to prior therapies. The trial aims to assess safety, tolerability, and efficacy, with interim results showing favorable survival rates and response rates. MAIA maintains strong liquidity and considers an accelerated approval pathway.
MAIA Biotechnology, Regeneron expand clinical supply agreement
MAIA Biotechnology amended its 2021 clinical supply agreement with Regeneron to expand the THIO-101 Phase 2 trial, assessing THIO with Libtayo for advanced NSCLC patients resistant to previous treatments. MAIA sponsors the trial, with Regeneron providing Libtayo, and expects to start enrolling new patients soon, potentially aiming for accelerated U.S. approval.
Drug Development Updates
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