A review of mirvetuximab soravtansine-gynx in folate receptor alpha-expressing platinum-resistant ovarian cancer.

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Judith A Smith, Patrick Medina, Mary Miao, Kathleen N Moore
{"title":"A review of mirvetuximab soravtansine-gynx in folate receptor alpha-expressing platinum-resistant ovarian cancer.","authors":"Judith A Smith, Patrick Medina, Mary Miao, Kathleen N Moore","doi":"10.1093/ajhp/zxaf011","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the pharmacology, efficacy, safety, and dosing and administration considerations (including adjusted ideal body weight [AIBW] dosing) for mirvetuximab soravtansine-gynx, a first-in-class folate receptor alpha (FRα)-directed antibody-drug conjugate for platinum-resistant ovarian cancer (PROC).</p><p><strong>Summary: </strong>A literature search was conducted in PubMed using the terms \"ovarian cancer\" and \"mirvetuximab soravtansine\" of articles published from inception to April 16, 2024. Relevant publications, abstracts, and clinical trials were reviewed. Mirvetuximab soravtansine-gynx is dosed at 6 mg/kg AIBW every 3 weeks and comprises an FRα-binding antibody, a hydrophilic disulfide linker, and a maytansinoid DM4 payload. Mirvetuximab soravtansine-gynx binds to FRα, which induces receptor-mediated internalization, lysosomal degradation, and release of DM4-containing cytotoxic metabolites. Meaningful anticancer activity in PROC was demonstrated in the single-arm phase 2 SORAYA trial (objective response rate, 32.4%; 95% confidence interval, 23.6%-42.2%) and the confirmatory, randomized phase 3 MIRASOL trial (median progression-free survival with mirvetuximab soravtansine-gynx vs chemotherapy, 5.62 vs 3.98 months; hazard ratio, 0.65; 95% confidence interval, 0.52-0.81; P < 0.0001]). Ocular disorders (eg, keratopathy and blurred vision), nausea, diarrhea, and fatigue were among the most common adverse events (AEs) that occurred during clinical trials.</p><p><strong>Conclusion: </strong>This review of trial data and pharmacology information for AIBW dosing of mirvetuximab soravtansine-gynx will help support its integration into the PROC treatment landscape. The review also discusses recommendations for prophylaxis, monitoring, and management of common AEs, including eye drop regimens, to mitigate ocular events. Mirvetuximab soravtansine-gynx is an effective, novel agent for PROC that targets a newly established biomarker. Established interventions can help mitigate AEs and support the safe use of mirvetuximab soravtansine-gynx.</p>","PeriodicalId":7577,"journal":{"name":"American Journal of Health-System Pharmacy","volume":" ","pages":"522-536"},"PeriodicalIF":2.1000,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12094874/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Health-System Pharmacy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ajhp/zxaf011","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

Purpose: To evaluate the pharmacology, efficacy, safety, and dosing and administration considerations (including adjusted ideal body weight [AIBW] dosing) for mirvetuximab soravtansine-gynx, a first-in-class folate receptor alpha (FRα)-directed antibody-drug conjugate for platinum-resistant ovarian cancer (PROC).

Summary: A literature search was conducted in PubMed using the terms "ovarian cancer" and "mirvetuximab soravtansine" of articles published from inception to April 16, 2024. Relevant publications, abstracts, and clinical trials were reviewed. Mirvetuximab soravtansine-gynx is dosed at 6 mg/kg AIBW every 3 weeks and comprises an FRα-binding antibody, a hydrophilic disulfide linker, and a maytansinoid DM4 payload. Mirvetuximab soravtansine-gynx binds to FRα, which induces receptor-mediated internalization, lysosomal degradation, and release of DM4-containing cytotoxic metabolites. Meaningful anticancer activity in PROC was demonstrated in the single-arm phase 2 SORAYA trial (objective response rate, 32.4%; 95% confidence interval, 23.6%-42.2%) and the confirmatory, randomized phase 3 MIRASOL trial (median progression-free survival with mirvetuximab soravtansine-gynx vs chemotherapy, 5.62 vs 3.98 months; hazard ratio, 0.65; 95% confidence interval, 0.52-0.81; P < 0.0001]). Ocular disorders (eg, keratopathy and blurred vision), nausea, diarrhea, and fatigue were among the most common adverse events (AEs) that occurred during clinical trials.

Conclusion: This review of trial data and pharmacology information for AIBW dosing of mirvetuximab soravtansine-gynx will help support its integration into the PROC treatment landscape. The review also discusses recommendations for prophylaxis, monitoring, and management of common AEs, including eye drop regimens, to mitigate ocular events. Mirvetuximab soravtansine-gynx is an effective, novel agent for PROC that targets a newly established biomarker. Established interventions can help mitigate AEs and support the safe use of mirvetuximab soravtansine-gynx.

mirvetuximab soravtansine- gyynx在叶酸受体表达铂耐药卵巢癌中的研究进展。
免责声明:为了加快文章的发表,AJHP在接受稿件后将尽快在网上发布。被接受的稿件已经过同行评审和编辑,但在技术格式化和作者校对之前会在网上发布。这些手稿不是记录的最终版本,稍后将被最终文章(按照AJHP风格格式化并由作者校对)所取代。目的:评估mirvetuximab soravtansine- gyynx的药理学、疗效、安全性、给药和给药考虑(包括调整后的理想体重[AIBW]剂量),mirvetuximab soravtansine- gyx是一种一流的叶酸受体α (FRα)靶向抗体-药物偶联物,用于治疗铂耐药卵巢癌(PROC)。摘要:在PubMed中检索自成立至2024年4月16日发表的文章,检索词为“卵巢癌”和“mirvetuximab soravtansine”。我们回顾了相关的出版物、摘要和临床试验。Mirvetuximab soravtansine- gyynx的剂量为每3周6mg /kg AIBW,包括fr结合抗体、亲水性二硫连接体和美坦素类DM4有效载荷。Mirvetuximab soravtansine- gyynx与FRα结合,诱导受体介导的内化、溶酶体降解和含有dm4的细胞毒性代谢物的释放。在单臂2期SORAYA试验中证明了PROC有意义的抗癌活性(客观缓解率,32.4%;95%可信区间,23.6%至42.2%)和验证性随机3期MIRASOL试验(mirvetuximab soravtansine- gyynx与化疗的中位无进展生存期,5.62个月对3.98个月;风险比0.65;95%置信区间为0.52-0.81;P < 0.0001])。眼部疾病(如角膜病变和视力模糊)、恶心、腹泻和疲劳是临床试验中最常见的不良事件(ae)。结论:本文回顾了mirvetuximab soravtansine- gyynx在AIBW中给药的试验数据和药理学信息,将有助于支持其融入PROC治疗领域。本综述还讨论了预防、监测和管理常见ae的建议,包括使用滴眼液方案来减轻眼部事件。Mirvetuximab soravtansine- gyynx是一种针对新建立的生物标志物的PROC有效的新型药物。已建立的干预措施有助于减轻不良反应,并支持mirvetuximab soravtansine- gyynx的安全使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
2.90
自引率
18.50%
发文量
341
审稿时长
3-8 weeks
期刊介绍: The American Journal of Health-System Pharmacy (AJHP) is the official publication of the American Society of Health-System Pharmacists (ASHP). It publishes peer-reviewed scientific papers on contemporary drug therapy and pharmacy practice innovations in hospitals and health systems. With a circulation of more than 43,000, AJHP is the most widely recognized and respected clinical pharmacy journal in the world.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信