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A DETAILED SAFETY PROFILE TO HELP YOU
SUPPORT YOUR PATIENTS THROUGH TREATMENT

 Most Common ARs Most Common ARs Laboratory Abnormalities Additional ARs of Interest Ocular ARs Longer-Term Follow-Up Safety Safety Single-Arm Study Safety

Adverse REACTIONS in ≥ 10% of patients who received ELAHERE in MIRASOL1

Adverse reaction

ELAHERE (n=218)

Standard chemotherapy* (n=207)

*Chemotherapy: paclitaxel, pegylated liposomal doxorubicin (PLD), topotecan.1

GASTROINTESTINAL DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Abdominal pain†
 34 3 23 2
Diarrhea
 29 1 17 0.5
Constipation
 27 0 19 1
Nausea
 27 2 29 2
Vomiting
 18 3 18 1

†Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort.1

EYE DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Blurred vision‡
 45 9 3 0
Keratopathy§
 37 11 0 0
Dry eye
 29 3 5 0
Photophobia
 18 0.5 0.5 0
Cataract#
 16 3 0.5 0

‡Blurred vision includes vision blurred, vitreous floaters, visual acuity reduced, diplopia, accommodation disorder, and visual impairment.1

§Keratopathy includes corneal disorder, corneal epithelial microcysts, keratitis, keratopathy, corneal deposits, punctate keratitis, and corneal opacity.1

Dry eye includes dry eye and lacrimation increased.1

#Cataract includes cataract and cataract nuclear.1

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Fatigue||
 47 3 41 7

‖Fatigue includes fatigue and asthenia.1

NERVOUS SYSTEM DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Peripheral neuropathy**
 37 4 23 4
Headache
 14 0 10 0

**Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, hypoesthesia, polyneuropathy, neurotoxicity, and peripheral sensorimotor neuropathy.1

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Musculoskeletal pain††
 31 1 21 2

††Musculoskeletal pain includes back pain, myalgia, neck pain, arthralgia, musculoskeletal pain, noncardiac chest pain, bone pain, pain in extremity, musculoskeletal stiffness, musculoskeletal chest pain, and musculoskeletal discomfort.1

METABOLISM AND NUTRITION DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Decreased appetite
 18 1 14 1

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Pneumonitis‡‡
 10 0.5 0.5 0

‡‡Pneumonitis includes pneumonitis, interstitial lung disease, respiratory failure, and organizing pneumonia.1

Laboratory abnormalities

Select laboratory abnormalities ≥10% for all grades in patients who received ELAHERE in MIRASOL1

Laboratory abnormality

ELAHERE (n=218)

Standard chemotherapy (n=207)

LIVER FUNCTION TESTS1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Increased AST
 57 0 14 0
Increased ALT
 38 1 15 1
Increased alkaline phosphatase
 30 1 13 1

CHEMISTRY1

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Decreased albumin
 21 1 27 2
Decreased magnesium
 21 1 29 2
Decreased sodium
 16 0 18 0
Decreased potassium
 15 1 11 1
Increased calcium
 12 0 5 0
Decreased bicarbonate
 11 0 11 0
Increased creatinine
 10 0 11 0

HEMATOLOGY1*

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Decreased lymphocytes
 27 3 42 11
Decreased leukocytes
 23 1 53 10
Decreased neutrophils
 22 1 45 17
Decreased hemoglobin
 18 1 63 8
Decreased platelets
 17 1 20 5

*The denominator used to calculate the rate varied from 63 to 214 (ELAHERE) and from 63 to 194 (IC chemotherapy) based on the number of patients with a baseline value and at least 1 posttreatment value.1
ALT=alanine aminotransferase; AST=aspartate aminotransferase; IC=investigator's choice.

Adverse reactions seen in MIRASOL

ELAHERE (n=218)1,2
Serious ARs (%)
24
(n=52)
Discontinuation due to ARs (%)
9
(n=20)
Common reasons for discontinuation (≥1%)
 Pneumonitis (2%), blurred vision (1%), and peripheral neuropathy (1%)
The most common serious ARs with ELAHERE (≥2%) were intestinal obstruction (5%), abdominal pain (3%), and pleural effusion (3%). Fatal ARs occurred in 3% of patients and included intestinal obstruction, dyspnea in the setting of subileus, neutropenic sepsis, cardiopulmonary failure, respiratory failure, ischemic stroke, and pulmonary embolus1

Dosage delays of ELAHERE due to an AR occurred in 54% of patients treated with ELAHERE. ARs that required dosage delays in ≥3% of patients included1:

  • Blurred vision (22%)
  • Keratopathy (19%)
  • Dry eye (7%)
  • Neutropenia (6%)
  • Pneumonitis (6%)
  • Photophobia (5%)
  • Cataract (4%)
  • Peripheral neuropathy (4%)

Dose reductions of ELAHERE due to an AR occurred in 34% of patients. ARs that required dose reductions in ≥3% of patients included1:

  • Blurred vision (14%)
  • Keratopathy (10%)
  • Peripheral neuropathy (6%)
  • Dry eye (5%)

Clinically relevant ARs that occurred in <10% of patients who received ELAHERE included infusion-related reactions/hypersensitivity (8%)1

The median duration of ELAHERE treatment was 5 months (range 0.69 to 27.4)1

AR=adverse reaction.

Additional adverse reactions of interest2,3

Adverse reactions reported in MIRASOL, in addition to safety data from the ELAHERE Prescribing Information

This analysis was not powered to demonstrate a difference in adverse reactions between ELAHERE and traditional chemotherapy.

Adverse reaction

ELAHERE (n=218)

Standard chemotherapy (n=207)

GENERAL2,3

  All Grades (%) All Grades (%)
Alopecia
 1 14

GASTROINTESTINAL2,3

  All Grades (%) All Grades (%)
Stomatitis
 3 11

HEMATOLOGIC2,3

  All Grades (%) All Grades (%)
Anemia
 10 34
Neutropenia
 11 29
Thrombocytopenia
 7 16

OCULAR ADVERSE REACTIONS SEEN AND MANAGED ACROSS CLINICAL TRIALS1,2*

Graph icon

Ocular adverse reactions were mostly Grade 1 or 21,2

59% of patients treated with ELAHERE had an ocular adverse reaction; 11% of patients experienced Grade 3 ocular adverse reactions1
Eye icon

Ocular adverse reactions completely or partially resolved for most patients1

Of the patients treated with ELAHERE who had an ocular adverse reaction, 53% had complete resolution and 38% had partial improvement†
Discontinuation due to ocular events icon

1% of patients discontinued ELAHERE due to ocular adverse reactions1
Graphic of a heart with a plus sign inside

Median time to onset of the first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6)1

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%).1

*In Study 0416, Study 0417, Study 0403 (NCT02631876), and Study 0401 (NCT01609556).1

†Partial improvement was defined as improvement by ≥1 grade from the worst grade at last follow-up.2

AIBW=adjusted ideal body weight.

Ocular adverse reactions seen in MIRASOL2,4

56% (n=122) of patients treated with ELAHERE experienced an ocular adverse reaction vs 9% of patients receiving standard chemotherapy.

  • Of the patients treated with ELAHERE who had an ocular adverse reaction, 51% had complete resolution and 42% had partial improvement
  • Of the remaining 7% who had no documented improvement, 5% were at Grade 1 and 2% were at Grade 2

This analysis was not powered to demonstrate a difference in adverse reactions between ELAHERE and traditional chemotherapy.

NO NEW SAFETY SIGNALS IDENTIFIED IN THE LONGER-TERM FOLLOW-UP5

Updated safety by treatment cohort in MIRASOL*

Adverse reaction

ELAHERE (n=218)

Standard chemotherapy† (n=207)

*Safety population.5

†Paclitaxel, n=82; PLD, n=76; topotecan, n=49.5

GASTROINTESTINAL DISORDERS5

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Diarrhea
 25 1 17 <1
Nausea
 27 2 29 2
Abdominal pain
 31 3 15 1
Stomatitis
 4 0 11 <1
Constipation
 27 <1 19 1

OCULAR5

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Blurred vision
 43 8 2 0
Keratopathy
 33 9 0 0
Dry eye
 29 4 2 0

HEMATOLOGIC5

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Neutropenia
 11 <1 29 17
Anemia
 10 <1 34 10
Thrombocytopenia
 8 <1 16 6

MISCELLANEOUS5

  All Grades (%) Grades 3-4 (%) All Grades (%) Grades 3-4 (%)
Fatigue
 30 2 25 5
Dyspnea
 8 1 13 3
Alopecia‡
 1 0 14 0
Peripheral neuropathy
 22 1 14 2

‡Grade 3 events not applicable for alopecia.5

Long-term safety adverse reactions are preferred terms and not grouped terms.5

Additional data from the ELAHERE Prescribing Information include1:

  • Fatigue
    • ELAHERE: 47% (all grades), 3% (Grades 3-4)
    • Standard chemotherapy: 41% (all grades), 7% (Grades 3-4)
  • Peripheral neuropathy
    • ELAHERE: 37% (all grades), 4% (Grades 3-4)
    • Standard chemotherapy: 23% (all grades), 4% (Grades 3-4)

No inference can be drawn from this data set. Follow-up analysis is exploratory and data are descriptive in nature.

Updated safety overview in MIRASOL5*
Adverse reaction, n (%) ELAHERE
(n=218)		 Standard chemotherapy†
(n=207)
Any TEAR
 210 (96) 194 (94)
Grade ≥3 TEAR
 93 (43) 112 (54)
Serious ARs
 55 (25) 68 (33)
Treatment-related serious ARs
 21 (10) 16 (8)
Dose reduction due to TEARs
 75 (34) 50 (24)
Dose delays/holds due to TEARs
 121 (56) 111 (54)
Discontinuations due to TEARs
 22 (10) 33 (16)
Deaths on study drug or within 30 days of last dose
 9 (4) 11 (5)

*Safety population.5

†Paclitaxel, n=82; PLD, n=76; topotecan, n=49.5
TEAR=treatment-emergent adverse reaction.

Long-term safety adverse reactions are preferred terms and not grouped terms.5

No inference can be drawn from this data set. Follow-up analysis is exploratory and data are descriptive in nature.

Resources for treatment

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  1. ELAHERE. Package insert. AbbVie; 2025.
  2. Moore KN, Angelergues A, Konecny GE, et al. N Engl J Med. 2023;389(23):2162-2174. doi:10.1056/NEJMoa2309169
  3. Data on file, AbbVie Inc. ABVRRTI80218.
  4. Data on file, AbbVie Inc. ABVRRTI80247.
  5. Coffman L, You B, Hamilton E, et al. Phase 3 MIRASOL trial: updated overall survival results of mirvetuximab soravtansine (MIRV) versus investigator's choice (IC) chemotherapy in patients (pts) with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression. Poster presented at: European Society for Medical Oncology Congress; September 13-17, 2024; Barcelona, Spain.