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
Optimism Grows in the Fight Against Cancer as Breakthroughs and Funding Increase
Oncolytics Biotech Inc. advances pelareorep therapy, showing significant survival benefits in breast cancer patients. Other biotech companies like Nurix, Incyte, Regeneron, and Foghorn also report promising developments in cancer treatments.
Regeneron's melanoma combo therapy benefit continues beyond two years
Regeneron's melanoma combo therapy, fianlimab plus Libtayo, shows 25% complete response and 57% objective response rates after 23 months in a Phase I trial, with ongoing Phase III studies.
Related Clinical Trials:
Evaluating Regeneron Pharmaceuticals And Competitors In Biotechnology Industry
Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.
Rate of Cardiovascular Adverse Events, Myocarditis May Be Low in Trials Assessing ICIs
A systematic review and meta-analysis of 83,315 patients from 589 trials showed low rates of cardiovascular adverse events (CVAEs) and myocarditis in those treated with immune checkpoint inhibitors (ICIs), with no significant differences except for cemiplimab. Dual ICIs increased myocarditis risk, but not CVAEs when combined with chemotherapy or tyrosine kinase inhibitors. Early recognition and treatment are crucial for optimal outcomes, though evidence-based monitoring strategies are lacking. Mortality from myocarditis was 37.7%, with potential reduction through systematic screening and specific treatments.
Libtayo shows durable survival benefits in phase 3 lung cancer study
Regeneron's Libtayo showed durable survival benefits in advanced NSCLC, with median OS of 26 months vs. 13 months for chemotherapy, and no new safety signals observed at five years.
MAIA Biotechnology Announces Positive Survival Updates in Phase 2 Study of THIO
16 patients surpassed 12-month survival follow-up, with THIO's substantial survival benefit in third line surpassing standard-of-care overall survival of 5.8 months, with a median survival follow-up of 10.6 months. Treatment with THIO followed by Libtayo® has been generally well-tolerated.
Related Clinical Trials:
MAIA Biotechnology Announces Positive Survival Updates in Phase 2 Study of THIO in Non
MAIA Biotechnology reports positive survival updates in Phase 2 THIO study for NSCLC, with 16 patients surpassing 12-month follow-up, and median survival in third line at 10.6 months, exceeding standard-of-care's 5.8 months.
Related Clinical Trials:
BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma
BioNTech announces positive Phase 2 results for mRNA immunotherapy BNT111 in advanced melanoma patients, showing significant improvement in ORR when combined with cemiplimab vs. historical control, with both monotherapies active. BNT111, part of BioNTech's FixVac platform, targets four tumor-associated antigens and has received FDA Fast Track and Orphan Drug designations for melanoma treatment.
Drug Development Updates
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