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
{"title":"针对晚期皮肤鳞状细胞癌患者的塞米普利单抗 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第6组的主要分析。","authors":"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","doi":"10.1016/j.jaad.2024.06.108","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Objectives: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%.</p><p><strong>Limitations: </strong>Nonrandomized study, nonsurvival primary end point.</p><p><strong>Conclusion: </strong>EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.</p>","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":" ","pages":"68-77"},"PeriodicalIF":12.8000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"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\",\"doi\":\"10.1016/j.jaad.2024.06.108\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Objectives: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%.</p><p><strong>Limitations: </strong>Nonrandomized study, nonsurvival primary end point.</p><p><strong>Conclusion: </strong>EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.</p>\",\"PeriodicalId\":17198,\"journal\":{\"name\":\"Journal of the American Academy of Dermatology\",\"volume\":\" \",\"pages\":\"68-77\"},\"PeriodicalIF\":12.8000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Academy of Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaad.2024.06.108\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Academy of Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaad.2024.06.108","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/7 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
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.
Background: 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).
Objectives: 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).
Methods: 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.
Results: 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%.
Limitations: Nonrandomized study, nonsurvival primary end point.
Conclusion: EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.
期刊介绍：
The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.
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