[2][5] 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.
[5] Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.
[5] 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.
[6] The trial enrolled participants whose tumors were positive for FRα expression as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
[6] 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.