Abstract：
Libtayo® (cemiplimab-rwlc) injection for intravenous use was recently approved by the US Food and Drug Administration (FDA) for locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC), both being the advanced stages of BCC. In the past, it was approved by the FDA for the treatment of metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC), both being the advanced stages of CSCC. Cemiplimab is a monoclonal antibody that works by blocking the programmed death-1 pathway. In two open-label, single-arm, phase 2 studies, cemiplimab was investigated for the treatment of advanced stages of BCC (study 1620, NCT03132636) and advanced stages of CSCC (study 1540, NCT02760498). The primary endpoint was objec-tive response rate (ORR) per independent central review. In the study 1620, both mBCC and laBCC received cemiplimab 350 mg every 3 weeks. ORR was 21% (6/28) and 31% (26/84) in the mBCC and laBCC groups, respectively. In the study 1520, mCSCC was divided into two groups: one receiving cemiplimab 350 mg every 3 weeks (Q3W) and another receiving 3-mg/kg cemiplimab every 2 weeks (Q2W); the third group, laCSCC, received cemiplimab 3 mg/kg every 2 weeks. ORR was 41% (23/56) in the Q3W group, 49% (29/59) in the Q2W group, and 44% (34/78) in the laCSCC group. An acceptable safety profile and antitumor activity was discovered in patients treated with cemiplimab. The recommended dosage for cemiplimab to treat advanced stages of BCC and CSCC is 350 mg every 3 weeks administered intravenously over 30 min.
摘要：
Libtayo®（cemiplimab-rwlc）静脉注射最近被美国食品和药物管理局（FDA）批准用于局部晚期基底细胞癌（laBCC）和转移性基底细胞癌（mBCC），都是BCC的高级阶段。在过去,它被FDA批准用于治疗转移性皮肤鳞状细胞癌（mCSCC）和局部晚期皮肤鳞状细胞癌（laCSCC），都是CSCC的高级阶段。Cemiplimab是一种单克隆抗体，通过阻断程序性死亡-1途径起作用。在两个开放标签中，单臂,第二阶段研究，研究了cemiplimab治疗晚期BCC（研究1620，NCT03132636）和晚期CSCC（研究1540，NCT02760498）。主要终点是每个独立中央审查的目标反应率（ORR）。在研究1620中,mBCC和laBCC均每3周接受cemiplimab350mg。mBCC和laBCC组的ORR分别为21%(6/28)和31%(26/84),分别。在研究1520中，mCSCC分为两组：一组每3周接受cemiplimab350mg（Q3W），另一组每2周接受3-mg/kgcemiplimab（Q2W）；第三组，laCSCC,每2周接受一次cemiplimab3mg/kg。Q3W组ORR为41%(23/56)，Q2W组的49%(29/59)，和44%(34/78)在laCSCC组。在接受cemiplimab治疗的患者中发现了可接受的安全性和抗肿瘤活性。cemiplimab治疗晚期BCC和CSCC的推荐剂量为每3周350mg，经30分钟静脉给药。
