Mirvetuximab soravtansine is
indicated for the treatment of adults with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.[2][3][4] Recipients are selected for therapy based on an FDA-approved test.[3][4]
Efficacy was evaluated in Study 0417 (NCT04296890), a single-arm trial of 106 participants with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.[3] Participants were permitted to receive up to three prior lines of systemic therapy.[3] All participants were required to have received
bevacizumab.[3] The trial enrolled participants whose tumors were positive for FRα expression as determined by the above assay.[3] Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.[3]
Efficacy was evaluated in Study 0416 (MIRASOL, NCT04209855), a multicenter, open-label, active-controlled, randomized, two-arm trial in 453 participants with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.[4] Participants were permitted to receive up to three prior lines of systemic therapy.[4] The trial enrolled participants whose tumors were positive for FRα expression as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.[4] Participants were randomized (1:1) to receive mirvetuximab soravtansine-gynx 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3 weeks or investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) until disease progression or unacceptable toxicity.[4] The results from this trial satisfy the post-marketing requirement of the previous accelerated approval for mirvetuximab soravtansine-gynx.[4]
^World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1).
hdl:10665/331046.
Clinical trial number NCT04296890 for "A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA)" at
ClinicalTrials.gov
Clinical trial number NCT04209855 for "A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL)" at
ClinicalTrials.gov