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Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer

Authors
 Kathleen N Moore  ;  Antoine Angelergues  ;  Gottfried E Konecny  ;  Yolanda García  ;  Susana Banerjee  ;  Domenica Lorusso  ;  Jung-Yun Lee  ;  John W Moroney  ;  Nicoletta Colombo  ;  Andrzej Roszak  ;  Jacqueline Tromp  ;  Tashanna Myers  ;  Jeong-Won Lee  ;  Mario Beiner  ;  Casey M Cosgrove  ;  David Cibula  ;  Lainie P Martin  ;  Renaud Sabatier  ;  Joseph Buscema  ;  Purificación Estévez-García  ;  Lan Coffman  ;  Shibani Nicum  ;  Linda R Duska  ;  Sandro Pignata  ;  Fernando Gálvez  ;  Yuemei Wang  ;  Michael Method  ;  Anna Berkenblit  ;  Diana Bello Roufai  ;  Toon Van Gorp  ;  Gynecologic Oncology Group Partners and the European Network of Gynaecological Oncological Trial Groups 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.389(23) : 2162-2174, 2023-12 
Journal Title
NEW ENGLAND JOURNAL OF MEDICINE
ISSN
 0028-4793 
Issue Date
2023-12
MeSH
Antibodies ; Monoclonal ; Humanized / administration & dosage ; Antibodies ; Monoclonal ; Humanized / adverse effects ; Antibodies ; Monoclonal ; Humanized / therapeutic use ; Carcinoma ; Ovarian Epithelial* / drug therapy ; Carcinoma ; Ovarian Epithelial* / genetics ; Drug Resistance ; Neoplasm / genetics ; Female ; Folate Receptor / antagonists & inhibitors ; Folate Receptor / genetics ; Humans ; Immunoconjugates / administration & dosage ; Immunoconjugates / adverse effects ; Immunoconjugates / therapeutic use ; Maytansine* / administration & dosage ; Maytansine* / adverse effects ; Maytansine* / analogs & derivatives ; Maytansine* / therapeutic use ; Ovarian Neoplasms* / drug therapy ; Ovarian Neoplasms* / genetics ; Platinum Compounds / pharmacolo
Keywords
Among participants with platinum-resistant ; FRα-positive ovarian cancer ; treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen ; MIRASOL ClinicalTrials.gov number ; NCT.)
Abstract
BACKGROUND Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody-drug conjugate targeting folate receptor a (FR alpha), is approved for the treatment of platinum-resistant ovarian cancer in the United States. METHODS We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator's choice of chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. Participants who had previously received one to three lines of therapy and had high FRa tumor expression (>= 75% of cells with >= 2+ staining intensity) were randomly assigned in a 1:1 ratio to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary end point was investigator-assessed progression-free survival; key secondary analytic end points included objective response, overall survival, and participant-reported outcomes. RESULTS A total of 453 participants underwent randomization; 227 were assigned to the MIRV group and 226 to the chemotherapy group. The median progression-free survival was 5.62 months (95% confidence interval [CI], 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P < 0.001). An objective response occurred in 42.3% of the participants in the MIRV group and in 15.9% of those in the chemotherapy group (odds ratio, 3.81; 95% CI, 2.44 to 5.94; P < 0.001). Overall survival was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; hazard ratio for death, 0.67; 95% CI, 0.50 to 0.89; P = 0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% vs. 54.1%), as did serious adverse events of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%). CONCLUSIONS Among participants with platinum-resistant, FR alpha-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response.
Full Text
https://www.nejm.org/doi/10.1056/NEJMoa2309169
DOI
10.1056/NEJMoa2309169
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Jung-Yun(이정윤) ORCID logo https://orcid.org/0000-0001-7948-1350
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/199279
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