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

Palleon Pharmaceuticals reports Phase I/II trial results of E-602 for solid tumours

Palleon Pharmaceuticals reports Phase I/II study results of E-602 with cemiplimab for PD-(L)1-resistant solid tumours. The combination therapy was well-tolerated, with no dose-limiting toxicities. Patients with tumour hypersialylation showed better clinical outcomes, including one partial response and six stabilisations. Tumour desialylation and immune modulation were observed in hypersialylation cases. E-602 is the first candidate in a new class of therapeutics targeting glyco-immunology.
quantisnow.com
·

MAIA Biotechnology Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial ...

MAIA Biotechnology, Inc. filed a Form 8-K on November 8, 2024, detailing new efficacy data from its Phase 2 THIO-101 clinical trial, a business presentation, and a summary of its partnership with Regeneron, all posted on its website.
benzinga.com
·

Assessing Regeneron Pharmaceuticals's Performance Against Competitors In ...

Regeneron Pharmaceuticals is compared against key competitors in the Biotechnology industry, revealing lower P/E, P/B, and P/S ratios suggesting potential undervaluation, but a low ROE indicating lower profitability efficiency. High EBITDA and gross profit levels show strong operational performance, while low revenue growth may be a concern.
biospace.com
·

MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected ...

MAIA Biotechnology announces late-breaking abstract on THIO-101 Phase 2 trial in NSCLC, to be presented at SITC 2024, highlighting long-term benefits of THIO sequenced with cemiplimab.
markets.ft.com
·

MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates

MAIA Biotechnology announces late-breaking abstract on THIO-101 Phase 2 trial in NSCLC, to be presented at SITC 2024, highlighting long-term benefits of THIO sequenced with cemiplimab.
morningstar.com
·

MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected for ...

MAIA Biotechnology presents THIO-101 Phase 2 updates at SITC 39th Annual Meeting, highlighting long-term benefits of THIO sequenced with cemiplimab in NSCLC patients.
placera.se
·

MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected

MAIA Biotechnology's THIO-101 Phase 2 trial updates selected for SITC 2024, showing efficacy and safety of THIO combined with cemiplimab in advanced NSCLC patients resistant to standard therapies.
biospace.com
·

Regeneron Reports Third Quarter 2024 Financial and Operating Results

Q3 2024 revenues up 11% to $3.72 billion; Dupixent global net sales by Sanofi up 23% to $3.82 billion; U.S. net sales for EYLEA HD and EYLEA up 3% to $1.54 billion; Libtayo global net sales up 24% to $289 million; GAAP diluted EPS up 30% to $11.54; FDA approves Dupixent for COPD and eosinophilic phenotype; positive results for Dupixent in CSU and BP trials.
© Copyright 2025. All Rights Reserved by MedPath