FDA Approval Summary: Abatacept for prophylaxis of acute graft versus host disease

IF 10 1区医学 Q1 ONCOLOGY

Clinical Cancer Research Pub Date : 2025-05-28 DOI:10.1158/1078-0432.ccr-25-0688

Kelly J. Norsworthy, Donna R. Rivera, Joseph Wynne, Jian Zhao, Robyn Konicki, Aida Kuzucan, Jonathon Vallejo, Ruby Leong, Olanrewaju O. Okusanya, Brian Booth, Paul G. Kluetz, Richard Pazdur, R. Angelo de Claro

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引用次数: 0

Abstract

In December 2021, FDA approved abatacept (Orencia; Bristol Myers Squibb) in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) as the first drug for prophylaxis of acute graft versus host disease (aGVHD) in adults and pediatric patients 2 years and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD). Study IM101311 included a randomized (1:1), double-blind evaluation of abatacept (N=73) versus placebo (N=69) +CNI+MTX as aGVHD prophylaxis in patients ≥6 years undergoing an 8/8 HLA-matched URD HSCT. Overall survival (OS) and Grade II-IV aGVHD free survival at Day 180 post-transplantation for abatacept versus placebo showed hazard ratio (HR) 0.33 (95% CI 0.12-0.93) and 0.54 (0.35-0.83), respectively. A second study, IM101841, was conducted using real-world data from Center for International Blood and Marrow Transplant Research (CIBMTR) registry for abatacept +CNI+MTX (N=54) versus CNI+MTX (N=162) in patients who underwent 7/8 mismatched URD HSCT. Day 180 OS was 98% (95% CI: 78, 100) with abatacept +CNI+MTX versus 75% (95% CI: 67, 82) with CNI+MTX. Serious adverse reactions included cytomegalovirus and Epstein-Barr Virus reactivation. An additional study in patients 2 to < 6 years was required as a condition of the approval.

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FDA批准概要：abataccept用于预防急性移植物抗宿主病

2021年12月，FDA批准了abataccept (Orencia；Bristol Myers Squibb)联合钙调磷酸酶抑制剂（CNI）和甲氨蝶呤（MTX）作为预防来自匹配或1个等位基因不匹配的非亲属供体（URD）进行造血干细胞移植（HSCT）的成人和2岁及以上儿童患者急性移植物抗宿主病（aGVHD）的第一种药物。研究IM101311纳入了一项随机（1:1）双盲评估，在接受8/8 hla匹配的URD HSCT患者中，阿巴接受（N=73）与安慰剂(N=69) +CNI+MTX作为aGVHD预防的患者≥6年。abatacept与安慰剂相比，移植后180天的总生存期（OS）和II-IV级无aGVHD生存期的风险比（HR）分别为0.33 （95% CI 0.12-0.93）和0.54（0.35-0.83）。第二项研究IM101841使用来自国际血液和骨髓移植研究中心（CIBMTR）注册中心的真实数据，对接受7/8不匹配的URD HSCT的患者进行abataccepept +CNI+MTX （N=54）与CNI+MTX （N=162）。第180天，abataccept +CNI+MTX组的OS为98% (95% CI: 78,100)，而CNI+MTX组的OS为75% （95% CI: 67,82）。严重的不良反应包括巨细胞病毒和eb病毒再激活。另一项针对患者2 - 1的研究；6年是批准的条件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Cancer Research 医学-肿瘤学

CiteScore

20.10

自引率

1.70%

发文量

1207

审稿时长

2.1 months

期刊介绍： Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.