Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma
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ADIS DRUG EVALUATION
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma Arnold Lee1 · Sean Duggan1 · Emma D. Deeks1
© Springer Nature Switzerland AG 2020
Abstract Cemiplimab (Libtayo®) is an antibody immunotherapy that stimulates an anti-cancer response via programmed cell death protein-1 (PD-1) blockade. It is the first approved treatment in the USA and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. Approval was based largely on positive results from the phase II EMPOWER-CSCC 1 trial in this patient population. In this pivotal trial, treatment with intravenous cemiplimab 3 mg/kg once every 2 weeks or 350 mg once every 3 weeks resulted in a clinically significant objective response rate across laCSCC and mCSCC patient groups. Furthermore, responses appear to be durable, as the median duration of response has not yet been reached. Similarly, the median overall survival has also not yet been reached as of the latest data cut-off date. The safety and tolerability profile of cemiplimab was acceptable, with most immune-related adverse events being clinically manageable with appropriate therapy or discontinuation of cemiplimab. Overall, cemiplimab has a durable, clinically significant effect and an acceptable tolerability and safety profile. As the first approved treatment for this indication, cemiplimab represents a welcome therapeutic advance for patients with advanced CSCC. Cemiplimab: clinical considerations in advanced cutaneous squamous cell carcinoma First approved systemic treatment in patients who are not candidates for curative radiotherapy or surgery Human IgG monoclonal antibody that binds to PD-1 to potentiate an anti-cancer immune response Clinically significant objective response rate with durable efficacy Acceptable safety and tolerability profile
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11987502. The manuscript was reviewed by: K. Ashack, Department of Dermatology, University of Illinois at Chicago, Chicago, IL, USA; G. Daniels, Department of Medicine, Moores UCSD Cancer Center, La Jolla, CA, USA. * Arnold Lee [email protected] 1
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1 Introduction Cutaneous squamous cell carcinoma (CSCC) is a non-melanoma skin cancer, which in the USA affected ~ 700,000 people [1] and was responsible for ~ 3900–8800 deaths (2012 estimates) [2]. In Europe, the age-standardised incidence of CSCC was 9–96 per 100,000 males and 5–68 per 100,000 females (2002–2007 estimates) [3]. Most simple CSCC cases can be surgically treated with a > 90% cure rate [4]; however, ≤ 5% of patients may present with non-resectable disease [5]. These cases of advanced CSCC include locally advanced (laCSCC) or metastatic (mCSCC) disease [6]. Until recently, treatment options for such patients have been limited to off-label chemotherapy or anti-epidermal growth
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