Department of Dermatology, Saudi German Hospital and Clinic, Dubai, United Arab Emirates.
Dermatol Ther. 2021 Nov;34(6):e15184. doi: 10.1111/dth.15184. Epub 2021 Nov 8.
Cemiplimab, a high-affinity, highly potent human monoclonal antibody that binds to the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) receptor, is the only drug to attain Food and Drug Administration (FDA) approval and marketing authorization from the European Commission for use in patients with metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation therapy as a first- or later-line treatment. In pivotal phase II clinical testing, cemiplimab showed rapid and substantial antitumor efficacy and acceptable safety. This systematic review was aimed at evaluating the efficacy and safety of cemiplimab in patients with advanced CSCC. To this end, I reviewed EMBASE, MEDLINE, PubMed, and clinical trial registries/databases by using the following keywords alone or in combination: "cemiplimab," "Libtayo," "cutaneous squamous cell carcinoma," "REGN2810," and "SER439684." Cemiplimab showed clinical efficacy and considerable safety and was associated with low rates of treatment discontinuation (7%) and death (3%). However, the current recommendation is primarily based on only phase II clinical testing due to the absence of an approved comparator agent.
西普单抗是一种高亲和力、高效能的人源单克隆抗体，能与程序性死亡受体 1（PD-1）/程序性死亡配体 1（PD-L1）受体结合，是唯一获得美国食品和药物管理局（FDA）批准和欧盟委员会上市许可的药物，用于治疗不适合根治性手术或根治性放射治疗的转移性和局部晚期皮肤鳞状细胞癌（CSCC）患者，作为一线或二线治疗药物。在关键性的 II 期临床试验中，西普单抗显示出快速和显著的抗肿瘤疗效和可接受的安全性。本系统评价旨在评估西普单抗在晚期 CSCC 患者中的疗效和安全性。为此，我检索了 EMBASE、MEDLINE、PubMed 以及临床试验注册数据库/数据库，使用了以下单独或组合的关键词：“cemiplimab”、“Libtayo”、“cutaneous squamous cell carcinoma”、“REGN2810”和“SER439684”。西普单抗显示出临床疗效和相当的安全性，停药率（7%）和死亡率（3%）均较低。然而，由于缺乏批准的对照药物，目前的推荐主要基于 II 期临床试验。
