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Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

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Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

ORDER ELAHERE

THE FIRST TREATMENT TO SHOW STATISTICALLY SIGNIFICANT IMPROVEMENTS IN FRα+ PLATINUM-RESISTANT OVARIAN CANCER1-3

PFS: Statistically significant improvement vs standard chemotherapy1,2

ELAHERE reduced risk of disease progression or death by 35% vs standard chemotherapy1*

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Primary endpoint: Progression-free survival with ELAHERE vs standard single-agent chemotherapy (ITT population)1

Primary Endpoints: Progression-Free Survival with ELAHERE vs Standard Single Agent Chemotherapy (ITT Population)

*Risk reduction derived from the hazard ratio (HR=0.65).
†Two-sided P value based on stratified log-rank test.

OS: First and only FRα-targeted treatment to deliver a statistically significant improvement in PROC2,3

ELAHERE delivered longer median overall survival than standard chemotherapy1

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Secondary endpoint: Overall survival with ELAHERE vs standard chemotherapy1

Secondary Endpoint: Overall Survival with ELAHERE vs Standard Chemotherapy

ELAHERE reduced risk of death by 33% vs standard chemotherapy1§

‡Two-sided P value based on stratified log-rank test.
§Risk reduction derived from the hazard ratio (HR=0.67).

ORR: Statistically significant improvement vs standard chemotherapy1

Complete responses: 11 patients with ELAHERE vs 0 patients with standard chemotherapy4

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Secondary endpoint: Overall response rate1,4

Secondary Endpoint: Overall response rate Secondary Endpoint: Overall response rate
  • Median duration of response: 6.77 months (n=95; 95% CI: 5.62, 7.89) with ELAHERE vs 4.47 months (n=36; 95% CI: 4.17, 5.82) with standard chemotherapy; HR: 0.64 (95% CI: 0.410, 0.993)4
  • In the ITT population, 13.7% of patients treated with ELAHERE (n=31/227) had progressive disease vs 27.4% of patients treated with standard chemotherapy (n=62/226)2
  • CA-125 response: 58.0% with ELAHERE (n=181; 95% CI: 50.5, 65.3) vs 30.3% with standard chemotherapy (n=155; 95% CI: 23.2, 38.2)2

‖Two-sided P value based upon Cochran-Mantel-Haenszel (CMH) test.
N values are based on the number of patients with measurable disease at baseline.

MIRASOL: The first and only positive phase 3 study vs single-agent chemotherapy in FRα+ PROC2

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 cancer2#

Patient population (N=453)

Key eligibility:

  • Platinum-resistant disease: PFI ≤6 months
  • FRα positive: ≥75% of viable tumor cells staining with ≥2+ intensity
1:1 Randomization 1:1 Randomization

ELAHERE (n=227)
(6 mg/kg AIBW q3w)

Investigator’s choice chemotherapy (n=226)**:

  • 41% paclitaxel (n=92)
  • 36% PLD (n=81)
  • 23% topotecan (n=53)

Primary endpoint:
PFS by investigator

Key secondary endpoints:

  • OS
  • ORR by investigator
  • PRO
  • Patients received 1-3 lines of prior systemic therapy; prior bevacizumab and PARPi therapy allowed2
  • Patients with BRCA mutations were allowed in the study2
  • Patients with primary platinum-refractory disease, defined as progression-free interval <3 months, were excluded2
  • Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease1

ELAHERE received accelerated approval based on SORAYA, a single-arm study of patients with FRα-positive, platinum-resistant ovarian cancer (N=106). Patients had received up to 3 lines of prior systemic therapy and prior treatment with bevacizumab was required. The primary endpoint was investigator-assessed ORR and the key secondary endpoint was investigator-assessed DOR.1,3

#Includes epithelial ovarian, fallopian tube, or primary peritoneal cancer.
**Paclitaxel was administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle (80 mg/m2 of BSA); PLD was administered intravenously on day 1 of a 4-week cycle (40 mg/m2); and topotecan was administered intravenously on days 1, 8, and 15 of a 4-week cycle (4 mg/m2) or was administered intravenously on days 1-5 of a 3-week cycle (1.25 mg/m2).2

MIRASOL patient characteristics2,5

Characteristics, n (%) ELAHERE
(n=227)		 Standard chemotherapy
(n=226)
Median age (range) Age in years 64 (32-88) 62 (29-87)
Stage at initial diagnosis
I-II 9 (4) 9 (4)
III 137 (60) 147 (65)
IV 76 (34) 65 (29)
BRCA mutation
Yes 33 (15) 36 (16)
No or unknown 198 (87) 190 (84)
Prior exposure
Bevacizumab 138 (61) 143 (63)
PARPi 124 (55) 127 (56)
Taxanes 227 (100) 224 (99)
Primary platinum-free interval
≤12 months 146 (64) 142 (63)
>12 months 80 (35) 84 (37)
Platinum-free interval
≤3 months 88 (39) 99 (44)
>3 to ≤6 months 138 (61) 124 (55)
Number of prior systemic therapies
1 29 (13) 34 (15)
2 90 (40) 88 (39)
3 108 (48) 104 (46)
Investigator’s choice of chemotherapya (Selected prior to randomization)
Paclitaxel 93 (41) 92 (41)
PLD 82 (36) 81 (36)
Topotecan 52 (23) 53 (23)
ECOG PS
0 130 (57) 120 (53)
1 97 (43) 101 (45)
2 0 3 (1)
Missing data 0 2 (1)
Race
White 156 (69) 145 (64)
Black 8 (4) 5 (2)
Asian 28 (12) 25 (11)
Not reported 32 (14) 49 (22)
Other 3 (1) 2 (1)
Ethnicity
Hispanic or Latino 12 (5) 15 (7)
Not Hispanic or Latino 177 (78) 163 (72)
Unknown 2 (1) 2 (1)
Not reported 35 (15) 45 (20)
Missing data 1 (<1) 1 (<1)

aInvestigators selected the chemotherapy prior to randomization in order to avoid selection bias.

Mirvetuximab soravtansine-gynx (ELAHERE) is recommended by the NCCN Guidelines® for Ovarian Cancer as an NCCN Category 2A preferred regimen for recurrence therapy in patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer6

Single-arm study (SORAYA) results: ~1 in 3 patients achieved a complete or partial response with ELAHERE1††

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ELAHERE Efficacy ELAHERE Efficacy
mDOR 6.9 months

(95% CI: 5.6, 9.7)

  • Stable disease (SD) was an exploratory endpoint. It is unknown if SD is a result of natural disease progression or treatment with ELAHERE
  • Consistent response rates and duration were demonstrated in the independent radiology review1

††Investigator-assessed per RECIST v1.1.

SORAYA: The first positive FRα biomarker-driven study1,2

SORAYA was a pivotal single-arm trial evaluating the efficacy and safety of ELAHERE in patients with FRα-positive, platinum-resistant ovarian cancer1,2

Patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (N=106)

ELAHERE 6 mg/kg AIBW‡‡ every 3 weeks, continued until disease progression or unacceptable toxicity

Primary endpoint3§§

  • ORR (investigator-assessed)

Key secondary endpoint3§§

  • DOR (investigator-assessed)
  • Patients had received 1 to 3 lines of prior systemic therapy1
  • Platinum resistance was defined as a disease recurrence within 6 months of treatment with platinum-based chemotherapy4
  • Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease1

‡‡Starting dose.
§§Investigator-assessed per RECIST v1.1.

SORAYA patient selection and characteristics

ELAHERE was studied in a population with high unmet need3,4

  • Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had 1 to 3 prior lines of therapy were selected for treatment with ELAHERE using the VENTANA FOLR1 IHC assay for FRα positivity1||||¶¶
Baseline patient characteristics,(N=106)3
Age, median years (range) 62 years (35-85)
Race, n (%)
White 102 (96)
Asian 2 (2)
Not Reported 2 (2)
ECOG PS, n (%)
0 60 (57)
1 46 (43)
BRCA mutation, n (%) Yes 21 (20)
Prior exposure, n (%)
Bevacizumab 106 (100)
Taxanes 105 (99)
Liposomal doxorubicin 75 (71)
PARPi 51 (48)
Topotecan 0 (0)
Prior systemic therapy, n (%)a
3 lines 54 (51)
2 lines 41 (39)
1 line 10 (9)

aOne patient had received 4 prior lines of therapy.3
||||Positive FRα expression of the tumor was defined as ≥75% of viable tumor cells staining with ≥2+ intensity by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.1,3
¶¶The platinum-free intervals (PFIs) were 0-3 months in 37% (after second- or third-line platinum-based chemotherapy) and 3-6 months in 60% of patients, respectively.3

Discover the safety profile of ELAHERE

View Safety Profile

How to Test for FRα

Testing for FRα is carried out at labs that have been validated to perform the VENTANA FOLR1 IHC assay.

See Validated Labs

How to Order ELAHERE

Please contact your participating specialty distributor or specialty pharmacy partners listed in the ELAHERE Ordering Information Sheet.

Download the List

AIBW=adjusted ideal body weight; BRCA=breast cancer gene; BSA=body surface area; CA-125=cancer antigen 125; CI=confidence interval; CR=complete response; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FOLR1=folate receptor 1; FRα=folate receptor alpha; HR=hazard ratio; IHC=immunohistochemistry; ITT=intent-to-treat; mDOR=median duration of response; mOS=median overall survival; mPFS=median progression-free survival; NCCN=National Comprehensive Cancer Network® (NCCN®); NE=not evaluable; ORR=overall response rate; OS=overall survival; PARPi=poly(ADP-ribose) polymerase inhibitor; PD=progressive disease; PFI=platinum-free interval; PFS=progression-free survival; PLD=pegylated liposomal doxorubicin; PR=partial response; PRO=patient-reported outcome; PROC=platinum-resistant ovarian cancer; RECIST=Response Evaluation Criteria in Solid Tumors; q3w=every 3 weeks.

IMPORTANT SAFETY INFORMATION

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.

WARNINGS and PRECAUTIONS

Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).

The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions, including lab 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 neutrophils.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

INDICATION

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

Please see Full Prescribing Information, including Boxed WARNING.

IMPORTANT SAFETY INFORMATION

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.

WARNINGS and PRECAUTIONS

Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).

The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions, including lab 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 neutrophils.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

INDICATION

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

Please see Full Prescribing Information, including Boxed WARNING.

References

  1. ELAHERE. Package insert. ImmunoGen, Inc.; 2024.
  2. Moore KN, Angelergues A, Konecny GE, et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. N Engl J Med. 2023;389:2162–2174.
  3. Matulonis UA, Lorusso D, Oaknin A, et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. J Clin Oncol. 2023;41(13):2436–2445.
  4. Data on file. ImmunoGen, Inc. Waltham, MA.
  5. Van Gorp T, Sabatier R, Konecny G, et al. Efficacy of mirvetuximab soravtansine in folate receptor alpha high, platinum-resistant ovarian cancer by type and number of prior treatment regimens: an exploratory analysis. Abstract presented at: 24th European Congress on Gynaecological Oncology; September 28–October 1, 2023; Istanbul, Türkiye.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer V1.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 1, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Call 1-833-ELAHERE1-833-ELAHERE for the ELAHERE Support Services Program

ORDER ELAHERE