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

医学 内科学 化疗 拓扑替康 置信区间 卵巢癌 优势比 肿瘤科 随机化 无进展生存期 随机对照试验 卡铂 外科 胃肠病学 癌症 顺铂
作者
Kathleen N. Moore,Antoine Angelergues,Gottfried E. Konecny,Yolanda García García,Susana Banerjee,Domenica Lorusso,Jung‐Yun Lee,John W. Moroney,Nicoletta Colombo,A. Roszak,Jacqueline M. Tromp,Tashanna Myers,Jeong‐Won Lee,Mario Beiner,Casey Cosgrove,David Cibula,Lainie P. Martin,Renaud Sabatier,Joseph Buscema,Purificación Estévez-García
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:389 (23): 2162-2174 被引量:136
标识
DOI:10.1056/nejmoa2309169
摘要

Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), is approved for the treatment of platinum-resistant ovarian cancer in the United States.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 FRα 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.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%).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, NCT04209855.).
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