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
benzinga.com
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targetedonc.com
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Atlas Examines Tolerability of Hedgehog Pathway Inhibitors and Transition to IO in mBCC

Cemiplimab-rwlc is indicated for locally advanced BCC previously treated with a hedgehog pathway inhibitor (HHI) or for whom HHI is not appropriate, or metastatic BCC (mBCC) previously treated with HHI or for whom HHI is not appropriate. The approval for mBCC is based on tumor response rates and durability of response noted in a trial. Medical oncologists often continue treatment initiated by dermatology, especially due to progression. Patient-specific factors leading to HHI inappropriateness include cachexia, peripheral vascular disease, and patient refusal due to alopecia. HHIs are typically continued for 8-12 weeks, with discontinuation if no response or intolerable toxicity. Cemiplimab was investigated in a phase 2 study, showing an overall response rate of 22% by independent central review, with a median progression-free survival of 10 months and a 12-month overall survival rate of 83%. Treatment-emergent adverse events (AEs) with cemiplimab include fatigue, GI AEs, and hypertension. HHIs are often discontinued due to AEs like muscle spasms, arthralgias, fatigue, taste changes, and weight loss, which may persist for weeks to months after discontinuation.
pharmavoice.com
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Regeneron takes the long-haul approach to oncology, stumbles and all

Regeneron, despite being a latecomer in cancer therapies, aims to leverage its packed pipeline to become a leader in the next wave of oncology treatments. Dr. Israel Lowy, senior vice president of translational and clinical sciences in oncology, highlights the company's focus on combinations like Libtayo and fianlimab, which could rival existing treatments like Opdualag and Keytruda. Regeneron's journey includes pioneering bispecific antibodies and facing early challenges, but with ongoing clinical trials and collaborations, the company seeks to establish itself as a major player in cancer therapy.
benzinga.com
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Inquiry Into Regeneron Pharmaceuticals's Competitor Dynamics In Biotechnology Industry

Regeneron Pharmaceuticals' PE, PB, and PS ratios are lower than industry averages, suggesting potential undervaluation. High ROE, EBITDA, and gross profit indicate strong profitability. However, low revenue growth raises concerns about market expansion.
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The Role of Biomarkers in the Treatment of Metastatic NSCLC

Biomarker testing crucial in metastatic NSCLC, guiding precision medicine and treatment decisions. Actionable biomarkers like EGFR, ALK, and PD-L1 inform therapy. Immunotherapy, particularly ICIs, is a key treatment option, though PD-L1 has limitations. Emerging biomarkers like STK11, KEAP1, and SMARCA4 are under investigation to refine patient selection for immunotherapy.
benzinga.com
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Exploring The Competitive Space: Regeneron Pharmaceuticals Versus Industry Peers In ...

Regeneron Pharmaceuticals' P/E, P/B, and P/S ratios are lower than industry averages, suggesting potential undervaluation. High ROE, EBITDA, and gross profit indicate strong profitability, but low revenue growth raises concerns about future performance.
quantisnow.com
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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.
benzinga.com
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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.
oncnursingnews.com
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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.
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