cemiplimab 治疗晚期皮肤鳞状细胞癌的 2 期开放标签研究 (EMPOWER-CSCC-1)：第 1、2 和 3 组的最终长期分析，以及固定剂量治疗组 6 的主要分析。
A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6.
发表日期：2024 Sep 07
作者：
Brett G M Hughes, Alexander Guminski, Samantha Bowyer, Michael R Migden, Chrysalyne D Schmults, Nikhil I Khushalani, Anne Lynn S Chang, Jean-Jacques Grob, Karl D Lewis, George Ansstas, Fiona Day, Rahul Ladwa, Brian N Stein, Eva Muñoz Couselo, Friedegund Meier, Axel Hauschild, Dirk Schadendorf, Nicole Basset-Seguin, Badri Modi, Sophie Dalac-Rat, Lara A Dunn, Lukas Flatz, Laurent Mortier, Sarah Guégan, Lucie M Heinzerling, Janice M Mehnert, Sabiha Trabelsi, Ainara Soria-Rivas, Alexander J Stratigos, Claas Ulrich, Deborah J Wong, Marie Beylot-Barry, Paolo Bossi, Cristina Bugés Sánchez, Sunandana Chandra, Caroline Robert, Jeffery S Russell, Ann W Silk, Jocelyn Booth, Suk-Young Yoo, Frank Seebach, Israel Lowy, Matthew G Fury, Danny Rischin
来源：
J Am Acad Dermatol
摘要：
在 EMPOWER-CSCC-1 2 期研究 (NCT02760498) 中，cemiplimab 对转移性皮肤鳞状细胞癌 (mCSCC) 和局部晚期皮肤鳞状细胞癌 (laCSCC) 具有抗肿瘤活性。 laCSCC（第 1 组和第 2 组）、mCSCC 中的固定剂量 cemiplimab（第 3 组）以及 mCSCC/laCSCC 中固定剂量 cemiplimab 的初步分析（第 6 组）。患者接受 cemiplimab（每 2 周静脉注射 3 mg/kg）[组每 3 周一次（第 1 和 2 组）或 cemiplimab（350 毫克静脉注射[第 3 组和第 6 组]）。主要终点是客观缓解率（ORR）。根据事后敏感性分析（仅包括方案规定的影像评估期间），按方案呈现缓解持续时间 (DOR) 和无进展生存期 (PFS)。在 42.5 个月时，第 1-3 组的 ORR（n = 193）为 47.2%，估计 12 个月 DOR 为 88.3%，中位 PFS 为 26.0 个月。 8.7 个月时，第 6 组（n = 165 名患者）的 ORR 为 44.8%；未达到中位 DOR 和中位 PFS。治疗中出现的严重不良事件发生率（≥3 级）为第 1-3 组：31.1%，第 6 组：34.5%。非随机研究，非生存主要终点。EMPOWER-CSCC-1 提供了最大的长期疗效前瞻性数据晚期 CSCC 中抗程序性细胞死亡 1 疗法的安全性和安全性。版权所有 © 2024 American Academy of Dermatology, Inc. 由 Elsevier Inc. 出版。保留所有权利。
In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC).To report final analysis of weight-based cemiplimab in mCSCC and laCSCC (groups 1 and 2), fixed-dose cemiplimab in mCSCC (group 3), and primary analysis of fixed-dose cemiplimab in mCSCC/laCSCC (group 6).Patients received cemiplimab (3 mg/kg intravenously every 2 weeks [groups 1 and 2]) or cemiplimab (350 mg intravenously [groups 3 and 6]) every 3 weeks. The primary end point was objective response rate (ORR). Duration of response (DOR) and progression-free survival (PFS) are presented per protocol, according to post-hoc sensitivity analyses that only include the period of protocol-mandated imaging assessments.At 42.5 months, ORR for groups 1-3 (n = 193) was 47.2%, estimated 12-month DOR was 88.3%, and median PFS was 26.0 months. At 8.7 months, ORR for group 6 (n = 165 patients) was 44.8%; median DOR and median PFS were not reached. Serious treatment-emergent adverse event rates (grade ≥3) were groups 1-3: 31.1% and group 6: 34.5%.Nonrandomized study, nonsurvival primary end point.EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.