AI Article Synopsis
- Mirvetuximab soravtansine is an investigational drug designed to target and treat ovarian cancer by specifically binding to folate receptor-α and delivering a powerful agent called DM4 to the tumor.
- FORWARD I is the first Phase III clinical trial aimed at evaluating the safety and effectiveness of mirvetuximab soravtansine versus standard chemotherapy for women with specific types of advanced ovarian cancer that are resistant to platinum-based treatments.
- The study will randomly assign participants in a 2:1 ratio and focuses on measuring progression-free survival as the main goal, along with other key metrics like overall response rates and overall survival.
Article Abstract
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.
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| http://dx.doi.org/10.2217/fon-2017-0646 | DOI Listing |
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