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.
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.