Table 1.

Key eligibility criteria.

Key inclusion criteria

≥18 years of age

ECOG performance status of 0 or 1

Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal or fallopian tube cancer

FRα-high as detected by IHC with PS2+ staining (≥75% of tumor membrane staining at ≥2+ intensity)a

BRCA testing prior to study entry.b Somatic and germ-line BRCA-positive patients must have received prior PARPi therapy as maintenance following 1L therapy

Relapsed after 1L platinum-based chemotherapy and platinum-sensitivity (disease progression >6 months after last platinum treatment)

Appropriate for, currently on, or completed 2L platinum-based doublet + bevacizumab (‘triplet’) therapy

Received four to eight cycles of 2L platinum-based triplet therapy, which included ≥3 cycles of bevacizumab in combination with platinum-based chemotherapyc,d

CR, PR or SD after prior treatment with platinum-based triplet therapy in 2L

Randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in 2L

Stabilized or recovered (grade 1 or baseline) from all prior therapy-related toxicities (except alopecia) and no major surgeries for at least 4 weeks prior to the first dose of maintenance therapy

Adequate hematologic, liver and kidney functions

Key exclusion criteria

Endometroid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low-grade/borderline ovarian tumor

≥1 Line of prior chemotherapye

PD while on or following platinum-based triplet therapy

Received an intervening dose of bevacizumab after the last dose of triplet therapy before randomization

Prior wide-field radiotherapy affecting ≥20% of the bone marrow

Grade >1 peripheral neuropathy per CTCAE

Active or chronic corneal disorders, history of corneal transplantation or active ocular conditions requiring ongoing treatment/monitoringf

History of bowel obstruction related to underlying disease within 6 months before the start of maintenance study treatment

Prior treatment with MIRV or other FRα-targeting agents

^aFRα staining determined by VENTANA FOLR1 (FOLR1-2.1) RxDx assay.

^bLocal tumor or germline BRCA testing will be acceptable for stratification. If the patient has not been tested, recommend archival tumor samples to be assessed for tissue BRCA. All patients who have received prior 1L PARPi maintenance and/or bevacizumab are eligible.

^cIf the number of cycles received is less than six due to toxicity, this must be documented and toxicity assessed as unlikely related to bevacizumab.

^dIn the case of interval secondary cytoreductive surgery, patients are permitted to receive only two cycles of bevacizumab in combination with the last three cycles of 2L platinum-based chemotherapy doublet plus bevacizumab. In the case of primary cytoreductive surgery before 2L platinum-based chemotherapy doublet plus bevacizumab, patients must have received no fewer than three cycles of bevacizumab in combination with platinum-based chemotherapy after their surgery and before randomization.

^eLines of prior anticancer therapy are counted with the following considerations: neoadjuvant ± adjuvant therapies are considered one line of therapy if the neoadjuvant and adjuvant correspond to one fully predefined regimen; otherwise, they are counted as two prior regimens. Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently). Change due to toxicity will be considered part of the proceeding line of therapy.

^fThese include uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision.

1L: First-line; 2L: Second-line; CR: Complete response; CTCAE: Common Terminology Criteria for Adverse Events; ECOG: Eastern Cooperative Oncology Group; FRα: Folate receptor alpha; IHC: Immunohistochemistry; MIRV: Mirvetuximab soravtansine-gynx; PARPi: Poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor; PD: Progressive disease; PR: Partial response; PS2+: Positive staining 2+; SD: Stable disease.