Support and resources for you and your patients
FREQUENTLY ASKED QUESTIONS
About FRα
Why does FRα matter in ovarian cancer?
FRα is a folate transport protein that has limited expression on normal tissue—making it an attractive therapeutic target. Approximately 35% of patients with advanced ovarian cancer have tumors that express FRα at a level that may make them candidates for ELAHERE monotherapy.1-5
Learn more about FRα here.
FRα=folate receptor alpha.
How is FRα testing performed?
Testing for FRα is done on FFPE tissue collected at any time using standard IHC. Results are typically reported in 2 to 5 days once the specimen is received. Tumors with ≥75% of cells staining at ≥2+ intensity are considered FRα positive.6-8
Explore more about FRα testing here.
FRα=folate receptor alpha; FFPE=formalin-fixed paraffin-embedded; IHC=immunohistochemistry.
When can FRα testing be performed?
FRα testing can be performed at diagnosis or any time after. Many labs can perform the VENTANA FOLR1 IHC assay*—the first FDA-approved companion diagnostic test for FRα.7,9,10
Knowing your patients' FRα status can help you be ready to treat appropriate patients with ELAHERE as soon as they become platinum resistant.
Explore more about FRα testing here.
*VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
FOLR1=folate receptor 1; FRα=folate receptor alpha; IHC=immunohistochemistry.
Is FRα testing recommended for patients with ovarian cancer?
Yes, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer V.3.2025 recommend tumor molecular analysis, including FRα testing, for patients with recurrent disease to identify potential benefits from targeted therapies.11
FRα=folate receptor alpha; NCCN=National Comprehensive Cancer Network ® (NCCN®).
About ELAHERE
How does ELAHERE work?
ELAHERE is an antibody-drug conjugate (ADC) that binds to cell surface receptor FRα. Upon binding, ELAHERE is internalized by the cell and delivers a cytotoxic molecule. This prompts intracellular release of DM4, a potent cytotoxic microtubule inhibitor, resulting in cell death.5,12
Learn more about how ELAHERE works here.
FRα=folate receptor alpha.
Who are appropriate patients for ELAHERE?
ELAHERE is indicated for the treatment of adult patients with FRα-positive,* platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.5
*FRα positive is defined as ≥75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining based on an IHC assay.7
FRα=folate receptor alpha; IHC=immunohistochemistry.
Is mirvetuximab soravtansine-gynx (ELAHERE®) recommended in treatment guidelines?
Yes, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer V.3.2025 recommend mirvetuximab soravtansine-gynx (ELAHERE®) as a NCCN Category 1, Preferred regimen for recurrence therapy in patients with folate receptor-alpha positive (FRα-expressing tumors [≥75% positive tumor cells]), platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.7,11
FRα=folate receptor alpha; NCCN=National Comprehensive Cancer Network® (NCCN®).
Efficacy of ELAHERE
What was the design of the Phase 3 confirmatory study?
ELAHERE was studied in MIRASOL (N=453), a confirmatory, global, multicenter, randomized, open-label study evaluating the efficacy and safety of ELAHERE (n=227) vs IC chemotherapy (n=226; standard single-agent chemotherapy; paclitaxel, PLD, or topotecan) in FRα-positive,* platinum-resistant ovarian cancer.5,8
See the study design here.
*FRα positive is defined as ≥75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining based on an IHC assay.7
FRα=folate receptor alpha; IC=investigator's choice; IHC=immunohistochemistry; PLD=pegylated liposomal doxorubicin.
How effective was ELAHERE vs standard chemotherapy?
ELAHERE is the first and only treatment to show superior efficacy vs standard single-agent chemotherapy in FRα-positive,* platinum-resistant ovarian cancer.4,5,8†
ELAHERE demonstrated vs standard chemotherapy:
- Median PFS: 5.6 months (n=227; 95% CI: 4.3, 5.9) vs 4.0 months (n=226; 95% CI: 2.9, 4.5), P<0.0001 (primary endpoint)5,8‡
- Median OS: 16.5 months (n=227; 95% CI: 14.5, 24.6) vs 12.7 months (n=226; 95% CI: 10.9, 14.4), P=0.0046 (key secondary endpoint)5,8§
- ORR: 42% (n=95/225 for ELAHERE; 95% CI: 36, 49) vs 16% (n=36/224 for standard chemotherapy; 95% CI: 12, 22), P<0.0001 (key secondary endpoint)5,8
Explore more data from the Phase 3 study here.
*FRα positive is defined as ≥75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining based on an IHC assay.7
†MIRASOL was a confirmatory, global, multicenter, randomized, open-label study evaluating the efficacy and safety of ELAHERE vs investigator's choice chemotherapy in FRα-positive, platinum-resistant ovarian cancer; ELAHERE (n=227) vs standard single-agent chemotherapy (n=226; paclitaxel, pegylated liposomal doxorubicin, or topotecan).5,8
‡HR: 0.65 (95% CI: 0.52, 0.81).5
§HR: 0.67 (95% CI: 0.50, 0.88).5
CI=confidence interval; FRα=folate receptor alpha; HR=hazard ratio; IHC=immunohistochemistry; ORR=overall response rate; OS=overall survival; PFS=progression-free survival.
Did any patients in the study experience a complete response?
In the study, 5% of patients experienced complete response with ELAHERE vs 0% of patients with standard chemotherapy.5
42% of patients experienced overall response with ELAHERE (n=95/225; 95% CI: 36, 49), with 37% of those patients having a partial response (n=84). 16% of patients experienced partial response with standard chemotherapy (n=36/224; 95% CI: 12, 22).5
Safety of ELAHERE
What should I know about the BOXED WARNING for ELAHERE?
From the Prescribing Information for ELAHERE:
WARNING: 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
Ocular adverse reactions with ELAHERE were mostly Grade 1 or 28
- 59% of patients treated with ELAHERE had an ocular adverse reaction; 11% of patients experienced Grade 3 ocular adverse reactions5
Ocular adverse reactions completely or partially resolved for most patients5
- Of the patients treated with ELAHERE who had an ocular adverse reaction, 53% had complete resolution and 38% had partial improvement*
One percent of patients discontinued ELAHERE due to ocular adverse reactions.5
Median time to onset of the first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6).5
This pooled safety population reflects exposure to ELAHERE in 682 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer at 6 mg/kg AIBW administered intravenously once every 3 weeks until disease progression or unacceptable toxicity in 4 clinical trials: MIRASOL, SORAYA, NCT02631876, and NCT01609556. The median duration of treatment was 4.4 months (range: 1.0 to 30.0). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).5
Learn more here about eye care with ELAHERE.
*Partial improvement was defined as improvement by ≥1 grade from the worst grade at last follow-up.8
AIBW=adjusted ideal body weight.
What are the potential side effects of ELAHERE?
In a clinical study, the following side effects were observed:
- Rate of serious ARs in MIRASOL: 24% with ELAHERE5
- The most common (≥20%) ARs in the pooled safety population, including laboratory abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils5
Learn more about the safety of ELAHERE by visiting here.
ELAHERE has a BOXED WARNING for ocular toxicity. Learn more here.
AR=adverse reaction.
Eye care
Do my patients need to see an eye care provider (ECP) before starting ELAHERE?
Your patients will need a baseline eye exam when starting ELAHERE, performed by either an ophthalmologist or optometrist.5
Their ECP should help them fill out the Ocular Assessment Form that can be downloaded here.
What if my patients don't have an ECP?
You can help your patients find an ECP through the Eye Doctor Finder here.
ECP visits are submitted through patients' medical insurance and not their eye care plan.
What should I tell my patients about eye care?
Be sure to remind your patients to avoid wearing contact lenses while they are on treatment, and tell them that they may need to wear sunglasses. Their ECP will monitor their vision for potential changes and call out anything to you that may need attention.5
You can also let your patients know that creating an eye care plan, as well as using other available tools and resources, can help manage eye care during treatment with ELAHERE.
Learn more here about eye care during treatment with ELAHERE.
Are there resources to help with eye care?
There is an ocular brochure you can give your patients, as well as an eye care video they can view on the patient website here. You can also request a Patient Starter Kit for them, which includes lubricating eye drops and an eye drop tracker.
Dosing & administration
What is the recommended dosage of ELAHERE?
The recommended dosage of ELAHERE is 6 mg/kg AIBW administered once every 3 weeks (21-day cycle). The total dose of ELAHERE is calculated based on each patient's AIBW.5 You can find a dosing calculator here.
AIBW=adjusted ideal body weight.
How is ELAHERE administered?
ELAHERE is an IV infusion and is administered until disease progression or unacceptable toxicity.5
Learn more about administering ELAHERE here.
IV=intravenous.
If needed, is there a dose modification schedule?
The dose reduction schedule for ELAHERE is as follows5:
- Starting dose: 6 mg/kg AIBW q3w (21-day cycle)
- First dose reduction: 5 mg/kg AIBW q3w (21-day cycle)
- Second dose reduction: 4 mg/kg AIBW q3w (21-day cycle)*
Learn more about dose reductions for ELAHERE here.
*Permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.5
AIBW=adjusted ideal body weight; q3w=every 3 weeks.
Access & support
Is there a support program for eligible patients?
ELAHERE Support Services (ESS) offers programs and services for patients, including access and reimbursement support, copay assistance,* patient assistance, and Nurse Navigators.
Learn more about ESS access and support for your patients here.
*Terms and conditions apply. Patients are eligible for copay assistance if enrolled in private commercial health insurance and are not covered by state or federal healthcare programs and who meet the eligibility criteria. Patients will be enrolled for 12 months. There are no income requirements to participate in the program.
Whom should I contact for additional information about access and support?
For questions, connect with an ELAHERE Support Services program specialist by calling 1-833-ELAHERE (1-833-352-4373), Monday to Friday, 8 am to 8 pm ET, or emailing ELAHERESupport@cardinalhealth.com.
What resources are available for my patients?
There are several brochures that provide an overview of ELAHERE for your patients, including helpful materials about eye care. See what's available here.
Are any other educational resources available?
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