Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer

Inclusion Criteria

• •1. All patients must have a pathologically documented, definite diagnosis of epithelial cancer of the ovary, the fallopian tube or the peritoneum
• •2. Relapsed disease with a platinum-free interval \>3 months
• •3. All histologic subtypes of ovarian carcinoma including carcinosarcoma (malignant mixed Mullerian tumors, MMMT)
• •4. Patients with wildtype BRCA1/2 mutation status or with a deleterious BRCA1/2 mutation in germline or somatic testing if they underwent PARP inhibitor therapy in previous treatment line.
• •5. Patients must be willing to provide archival tumor tissue from current relapse or previous surgeries/biopsies for central confirmation of FRα high status by PS2+ scoring:
• •all tumors must exhibit ≥75% of tumor cells with FRα membrane staining and ≥ 2+ intensity by immunohistochemistry (IHC) using the Ventana FOLR1 (FOLR1 2.1) CDx assay.
• •6. Patients must have measurable disease or evaluable disease in combination with GCIG CA-125 criteria.
• •7. Patients had one or more prior lines of chemotherapy. The last line of chemotherapy should have included platinum and has resulted in a partial or complete response.
• •8. Major surgery (not including placement of vascular access device, tumor punch/scrape biopsies or secondary wound closure) must be completed four weeks prior to Day 1.
• •9. Patients must have adequate hematological, liver, cardiac and kidney function:
• •1. Hemoglobin ≥ 10.0 g/dL.
• •2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• •3. Platelet count ≥ 100 x 109/L.
• •4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
• •5. Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase/Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
• •6. Serum creatinine ≤ 1.5 x institutional ULN and glomerular filtration rate of at least 40 ml/minute according to Cockroft-Gault formula.
• •10. Patient is female and ≥18 years of age at the time of the first screening visit.
• •11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• •12. Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
• •13. Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently ster-ile. Permanent sterilization methods include hysterectomy, bi-lateral salpingectomy and bilateral oophorectomy) must have a negative serum pregnancy test within 3 days from day 1 of cycle 1 and agree to use a highly effective method of contraception while on study treatment and for at least 6 months after end of treatment. Such methods include:
• •1. Combined (estrogen and progestogen containing) hor-monal contraception associated with inhibition of ovulation:
• •* oral
• •* intravaginal
• •* transdermal
• •2. Progestogen-only hormonal contraception associated with inhibition of ovulation:
• •* oral
• •* injectable
• •* implantable
• •3. Intrauterine device (IUD)
• •4. Intrauterine hormone-releasing system ( IUS)
• •5. Bilateral tubal occlusion
• •6. Vasectomized partner
• •7. Sexual abstinence