Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC

Inclusion Criteria:

• Written informed consent and HIPAA authorization for release of personal health information.
• Must have operable tumor ≥ 1cm determined by and obtained less than 9 weeks after completion of standard NAC
• Must be able to meet study schedule: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC.
• Willing to undergo biopsy for research purposes only (before and after), and to allow surgical tissue sample from surgery to be used for research purposes
• May have symptoms however must be ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work)
• Demonstrate adequate organ function through labs
• Females of childbearing years must have a negative serum pregnancy test within 48 hours prior to dose 1 mirvetuximab soravtansine. NOTE: Sexually mature females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
• Females of childbearing potential must be willing to abstain from heterosexual activity or to use two effective methods of contraception from the time of informed consent until 4 months after the last dose of mirvetuximab soravtansine

Exclusion Criteria:

• Pregnant or breastfeeding, or plan to be pregnant within projected duration of the trial. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Has a known additional malignancy that is active and/or progressive requiring treatment within 3 years of first dose.
• Prior treatment with mirvetuximab soravtansine
• Treatment with any investigational drug within 6 weeks of first clinical dose
• Subjects with > Grade 1 peripheral neuropathy

• Active or chronic corneal disorder, including but not limited to the following:

  • Sjogren's syndrome
  • Fuchs corneal dystrophy (requiring treatment)
  • History of corneal transplantation
  • Active herpetic keratitis
  • Active ocular conditions requiring on-going treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision.
• Serious concurrent illness or clinically-relevant active infection
• Cytomegalovirus infection
• Any concurrent infectious disease, requiring IV antibiotics within 2 weeks of first dose of mirvetuximab soravtansine
• Significant cardiac disease including
• History of neurological conditions that would confound assessment of treatment-emergent neuropathy other than ≤ Grade 1 peripheral neuropathy including multiple sclerosis or other demyelinating disease and/or eaton-lambert syndrome (para-neoplastic syndrome)" Diabetes is allowed.
• History of hemorrhagic or ischemic stroke within 6 months prior to first dose of mirvetuximab soravtansine
• History of cirrhotic liver disease
• Previous clinical diagnosis of non-infectious pneumonitis or non-infectious interstitial lung disease
• Prior hypersensitivity to monoclonal antibodies
• History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to first dose of mirvetuximab soravtansine
• Required used of folate-containing supplements (e.g. for folate deficiency)