Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)

• ECOG PS 0-1
• Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
• If patients are BRCA positive, must have received treatment with PARP inhibitors
• Must be folate receptor alpha positive as defined by FRa positivity of >75% of tumor membrane staining at 2+ intensity or higher.
• Disease must have relapsed after 1 line of platinum-based therapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy
• Must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line. Must have received no less than 4 and no greater than 8 cycles in the second line
• Must have receirved, be currently be receiving, or be planned to receive paclitaxel, gemcitabine, pegylated lipsomal doxorubicin as the partner drug to platinum based therapy
• After completion of platinum based triple therapy and before randomization, patient must have achieved a CR, pR, or SD
• Before randomization must have either a) measurable disease, b) persistently elevated CA-125 or c) no evidence of disease and normalization of CA-125
• No endometrioid, clear cell, mucinous, or sarcomatous histology
• No more than 1 line of prior chemotherapy before planned triplet therapy
• No PD while on triple therapy
• No cirrhotic liver disease
• No severe cardiac disease
• No history of bowel obstruction, abdominal fistula, or GI perforation
• No folate deficiency
• No other malignancy within 3 years

• Primary
  • PFS
• Secondary
  • OS
  • Safety
  • PFS2
  • ORR
  • DOR
  • DFS
  • CA-125 response