Department of Obstetrics & Gynecology, Stephenson Oklahoma Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
Gynaecological Oncology, Leuven Cancer Institute, Leuven 3000, Belgium.
Future Oncol. 2018 Jul;14(17):1669-1678. doi: 10.2217/fon-2017-0646. Epub 2018 Feb 9.
Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the setting of platinum-resistant disease. Here we describe the rationale and design of FORWARD I (NCT02631876), the first randomized, multicenter Phase III study to compare the safety and efficacy of mirvetuximab soravtansine versus investigator's choice of chemotherapy in women with folate receptor-α-positive, platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients will be randomized in a 2:1 ratio. The primary end point is progression-free survival, and key secondary objectives include comparison of overall response rates, overall survival and duration of response.
米拉妥昔单抗soravtansine 是一种抗体药物偶联物，与叶酸受体-α高亲和力结合，为强效微管破坏剂 DM4 提供肿瘤靶向递送，已成为治疗卵巢癌的一种很有前途的研究药物，特别是在铂类耐药疾病的情况下。在这里，我们描述了 FORWARD I（NCT02631876）的原理和设计，这是第一项随机、多中心 III 期研究，旨在比较 mirvetuximab soravtansine 与研究者选择的化疗在叶酸受体-α阳性、铂类耐药的上皮性卵巢癌、原发性腹膜癌或输卵管癌女性中的安全性和疗效。患者将按 2:1 的比例随机分组。主要终点是无进展生存期，关键次要目标包括总缓解率、总生存期和缓解持续时间的比较。
