对患有晚期皮肤鳞状细胞癌（Empower-CSCC-1）患者Cemiplimab的2期开放标签研究：第1、2和3组的最终长期分析，以及固定剂量治疗组的主要分析6
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
影响因子:11.80000
分区:医学1区 Top / 皮肤病学1区
发表日期:2025 Jan
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
摘要
在第2阶段Empower-CSCC-1研究（NCT02760498）中，Cemiplimab表现出针对转移性皮肤皮肤鳞状细胞癌（MCSCC）的抗肿瘤活性，以及局部晚期的皮肤鳞状细胞癌（LACSCC）。 3），以及MCSCC/LACCC中固定剂量Cemiplimab的一级分析（第6组）。患者每2周静脉内接受Cemiplimab（3 mg/kg）[组1和2]）或Cemiplimab（每3周静脉静脉静脉内[3和6]）接受了每3周。主要终点是客观响应率（ORR）。根据事后敏感性分析，响应持续时间（DOR）和无进展生存期（PFS）呈现，仅包括协议授权成像评估期。第42.5个月，1-3组（n = 193）的ORR为47.2％，为47.2％，估计为12个月的DOR为88.3％和Median Median PFF。在8.7个月时，第6组的ORR（n = 165例）为44.8％；未达到DOR和中位PF。严重的治疗急剧不良事件发生率（≥3级）是1-3：31.1％和第6组：34.5％的研究。非征服研究，非存在生存的主要终点。Empower-CSCC-CSCC-CSCC-CSCC-CSCC-CSCC-1提供了有关抗突出细胞死亡1的长期效力和先进CSCC中的长期疗效和安全性的最大预期数据。
Abstract
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.