A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）

Prior treatment

• Patients who meet any of the following criteria may not be enrolled in the study:
  • Participation in other clinical studies during the same period.
  • Patient with known prior hypersensitivity to monoclonal antibody therapy or maytansinoids, or to study drug and/or any of its excipients.
  • Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision.
  • Patients with prior treatment with MIRV or other FRα-targeting agents. (Only for patients in prospective cohort)
  • Pregnant or breast-feeding females. Women of childbearing potential must agree to use highly effective contraception while using study drug and for at least 7 months after the last dose of MIRV.
  • Current participation in any interventional study other than routine clinical practice.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

• Patients who meet all of the following inclusion criteria are eligible to participate in the study:
  • Female patients aged ≥18 years.
  • Patients must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  • Patients must have PD on or after the most recent anti-cancer therapy.
  • Patients must have FRα expression confirmed by VENTANA FOLR1 (≥ 25% of tumor cells with intensity ≥ 2 + after FRα staining).
  • Patients must have normal major organ function and be suitable for MIRV monotherapy or combination therapy according to clinical recommendations
  • Patients must have at least 1 evaluable lesion per RECIST v1.1 (radiologically assessed by the investigator).
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score must be 0-2.
  • All toxicities (except alopecia) associated with prior therapy must have recovered to ≤ grade 1 per common terminology criteria for adverse events （CTCAE）v5.0.
  • Patients must have had completed any major surgery at least 4 weeks prior to the first dose of MIRV, and have recovered or stabilized from postoperative complications of prior surgery.
  • Patients must have expected survival of at least 12 weeks as assessed by the investigator.
  • Patients must sign informed consent form（ICF）, and willingness and ability to comply with the study protocol, including scheduled treatment, regular follow-up, and examinations.