89% estimated event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo prior to surgery in a Phase 2 trial No disease recurrence among the 51% of patients who experienced a pathologic complete response in the primary analysis TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.

在第二阶段试验中接受Libtayo手术的II期至IV期可切除CSCC患者中，89%的患者在一年内估计无事件生存率在初步分析中经历病理完全缓解的51%患者中无疾病复发TARRYTOWN，N.Y.，2023年10月21日（GLOBE NEWSWIRE）-Regeneron Pharmaceuticals，Inc。

(NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.

（纳斯达克股票代码：REGN）今天宣布首次提出PD-1抑制剂Libtayo®（cemiplimab）作为II至IV期可切除皮肤鳞状细胞癌（CSCC）新辅助单药治疗研究方案的关键次要终点。国际2期临床试验的结果在2023年欧洲肿瘤内科学会（ESMO）大会的口头会议上提出，并同时发表在“柳叶刀肿瘤学”上。

“Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation. Additionally, risk of recurrence and death is a consideration for these patients,” said Neil D. Gross, M.D., F.A.C.S., Director of Clinical Research, Department of Head and Neck Surgery at the University of Texas MD Anderson Cancer Center and principal investigator of the trial.

Neil D.Gross说：“先进的，可切除的皮肤鳞状细胞癌可以在累积的治疗效果（通常是手术和放疗）之后导致患者功能和生活质量下降，此外，复发和死亡的风险是这些患者的考虑因素。，M.D.，F.a.C.S。，临床研究主任，德克萨斯大学MD安德森癌症中心头颈外科和该试验的首席研究员。

“Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma. These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.” The multicenter, single-arm Phase 2 trial included two parts.

“单机构试验和多中心2期试验的结果发现，新辅助cemiplimab在可切除的皮肤鳞状细胞癌患者中高度活跃，这些强有力的反应持久，转化为绝大多数患者的无事件生存一年和两年。“多中心，单臂2期试验包括两部分。

In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surger.

在第1部分中，患者（n=79）每三周接受一次350毫克Libtayo，最多四次剂量，然后进行治愈性手术。