General Information

Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate.

Elahere is specifically approved for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Elahere is supplied as an injection for intravenous administration. 

The recommended dose of Elahere is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity. The total dose of Elahere is calculated based on each patient’s AIBW using the following formula:

AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW) Female IBW (kg) = 0.9*height(cm) – 92

Pre-medicate with a corticosteroid, antihistamine, and antipyretic. Pre-medicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops.

Mechanism of Action

Elahere (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine-gynx is internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death.

Side Effects

Adverse effects associated with the use of Elahere may include, but are not limited to, the following:

laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin

The Elahere drug label comes with a Black Box Warning for ocular toxicity. Elahere can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of Elahere, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold Elahere for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue Elahere for Grade 4 ocular toxicities.

Clinical Trial Results

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial:

The FDA's accelerated approval was based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial. 

The single arm SORAYA trial enrolled 106 patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRα and who had been treated with one to three prior systemic treatment regimens – at least one of which included Avastin (bevacizumab). The primary endpoint was confirmed Objective Response Rate (ORR) as assessed by investigator and the key secondary endpoint was Duration of Response (DOR). Elahere demonstrated an ORR of 31.7%, including five complete responses (CRs). The median DOR was 6.9 months.