ELAHERE STUDY SAFETY PROFILE
Adverse events in ≥10% of patients who received ELAHERE in MIRASOL
Adverse event
ELAHERE
(n=218)
Standard chemotherapy
(n=207)
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Abdominal paina | 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 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Blurred visionb | 45 | 9 | 3 | 0 |
Keratopathyc | 37 | 11 | 0 | 0 | Dry eyed | 29 | 3 | 5 | 0 | Photophobia | 18 | 0.5 | 0.5 | 0 | Cataracte | 16 | 3 | 0.5 | 0 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Fatiguef | 47 | 3 | 41 | 7 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Peripheral neuropathyg | 37 | 4 | 23 | 4 |
Headache | 14 | 0 | 10 | 0 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Musculoskeletal painh | 31 | 1 | 21 | 2 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Decreased appetite | 18 | 1 | 14 | 1 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Pneumonitisi | 10 | 0.5 | 0.5 | 0 |
All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) | |
---|---|---|---|---|
Neutropenia | 11 | 0.9 | 29 | 17 |
Anemia | 10 | 0.9 | 34 | 10 |
aAbdominal pain includes
abdominal pain, abdominal pain upper, abdominal pain lower, and
abdominal discomfort.
bBlurred vision includes
vision blurred, vitreous floaters, visual acuity reduced,
diplopia, accommodation disorder, and visual impairment.
cKeratopathy includes corneal
disorder, corneal epithelial microcysts, keratitis, keratopathy,
corneal deposits, punctate keratitis, and corneal opacity.
dDry eye includes dry eye and
lacrimation increased.
eCataract includes cataract
and cataract nuclear.
fFatigue includes fatigue and
asthenia.
gPeripheral neuropathy
includes neuropathy peripheral, peripheral sensory neuropathy,
peripheral motor neuropathy, paresthesia, hypoesthesia,
polyneuropathy, neurotoxicity, and peripheral sensorimotor
neuropathy.
hMusculoskeletal pain includes
back pain, myalgia, neck pain, arthralgia, musculoskeletal pain,
non-cardiac chest pain, bone pain, pain in extremity,
musculoskeletal stiffness, musculoskeletal chest pain, and
musculoskeletal discomfort.
iPneumonitis includes
pneumonitis, interstitial lung disease, respiratory failure, and
organizing pneumonia.
Additional MIRASOL study AE information
ELAHERE (n=218)1,2 |
Standard chemotherapy (n=207)2 |
|
Grade ≥3 AEs (%) | 42 (n=91) |
54 (n=112) |
---|---|---|
Serious AEs (%) | 24 (n=52) |
33 (n=68) |
Discontinuations due to AEs (%) | 9 (n=20) |
16 (n=33) |
Common reasons for discontinuation (≥1%) | Pneumonitis (2%), blurred vision (1%), and peripheral neuropathy (1%) | Peripheral neuropathy (2%), thrombocytopenia (1%), and fatigue (1%) |
The most common (≥2%) serious AEs were intestinal obstruction (5%), abdominal pain (3%), and pleural effusion (3%). Fatal AEs occurred in 3% of patients, including 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 AE occurred in 54% of patients treated with ELAHERE. AEs which 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 AE occurred in 34% of patients. AEs which required dose reductions in ≥3% of patients included1:
- Blurred vision (14%)
- Keratopathy (10%)
- Peripheral neuropathy (6%)
- Dry eye (5%)
Clinically relevant AEs that occurred in <10% of patients who received ELAHERE in the MIRASOL study included infusion-related reactions/hypersensitivity (8%)1
1% of patients treated with ELAHERE reported alopecia (Grade 1) vs 14% of patients treated with standard chemotherapy (7% Grade 1 and 7% Grade 2)3
In the MIRASOL study, the median duration of ELAHERE treatment was 5 months (range: 0.69 to 27.4)1
Ocular events with ELAHERE from MIRASOL (n=218)2,4*
Ocular events were mostly Grade 1 or 22,4
- 56% of patients treated with ELAHERE had an ocular AE (n=122); of those who had an ocular AE, 14% were Grade ≥3 (n=30)4
- Of the patients treated with ELAHERE who had an ocular event (n=122), 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 23,4
- 1.8% of patients treated with ELAHERE discontinued due to ocular-related events2
- Median time to onset of first ocular AE was 5.4 weeks (range: 0.1 to 68.6)2
No corneal ulcerations or perforations have been reported2
*Data cutoff was March 6, 2023.2
†Partial improvement was defined
as improvement by ≥1 grade from the worst grade at last
follow-up.4
Laboratory abnormalities in MIRASOL1
Select laboratory abnormalities ≥10% for all grades in patients who received ELAHERE in MIRASOL
Laboratory abnormality
ELAHERE
(n=218)
Standard chemotherapy
(n=207)
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 |
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 |
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 |
aThe denominator used to calculate the rate varied from 63 to 214 (ELAHERE); 63 to 194 (IC chemo) based on the number of patients with a baseline value and at least one posttreatment value.
Adverse events reported in ≥10% of patients receiving ELAHERE in SORAYA1,3
Adverse event
(N=106)
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Blurred Visiona | 50 | 6.6 | 0 |
Keratopathyb | 37 | 8.5 | 0.9 | Dry eyec | 27 | 1.9 | 0 | Cataract | 18 | 2.8 | 0 | Photophobia | 17 | 0 | 0 | Eye paind | 10 | 0 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Fatiguee | 49 | 2.8 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Nausea | 40 | 0 | 0 |
Abdominal painf | 36 | 6.6 | 0 |
Diarrhea | 31 | 2.8 | 0 |
Constipation | 30 | 0.9 | 0 |
Vomiting | 19 | 0 | 0 |
Abdominal distension | 11 | 0 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Peripheral neuropathyg | 33 | 1.9 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Decreased appetite | 18 | 0.9 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Arthralgia | 17 | 0 | 0 |
Myalgia | 10 | 0 | 0 |
All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
---|---|---|---|
Dyspneah | 12 | 0 | 0 |
aBlurred vision includes
vision blurred, vitreous floaters, visual acuity reduced,
diplopia, presbyopia, accommodation disorder, visual impairment,
and refraction disorder.
bKeratopathy includes corneal
disorder, corneal epithelial microcysts, corneal epithelial
defect, keratitis, keratopathy, corneal deposits, and punctate
keratitis.
cDry eye includes dry eye and
lacrimation increased.
dEye pain includes eye pain
and ocular discomfort.
eFatigue includes fatigue and
asthenia.
fAbdominal pain includes
abdominal pain, abdominal pain upper, abdominal pain lower,
abdominal discomfort.
gPeripheral neuropathy
includes neuropathy peripheral, peripheral sensory neuropathy,
peripheral motor neuropathy, paresthesia, hypoesthesia,
polyneuropathy, and neurotoxicity.
hDyspnea includes dyspnea and
exertional dyspnea.
One patient reported Grade 1 alopecia after treatment with ELAHERE in the SORAYA study3‡
Clinically relevant AEs occurring in <10% of patients who received ELAHERE in SORAYA included1:
- Infusion-related reactions/hypersensitivity (9%)
- Pneumonitis (8%)
- Uveitis (1%)
Serious AEs occurred in 31% of patients. The most common (≥2%) serious AEs were1:
- Intestinal obstruction (8%)
- Ascites (4%)
- Infection (3%)
- Pleural effusion (3%)
Fatal AEs occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%)1
Permanent discontinuation due to AEs occurred in 11% of patients1
- The most common (≥2%) AEs leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%)
- One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation)
Dosage delays of ELAHERE due to an AE occurred in 39% of patients1
AEs which required dosage delays in ≥3% of patients included:
- Blurred vision (15%)
- Keratopathy (11%)
- Neutropenia (6%)
- Dry eye (5%)
- Cataracts (3%)
- Increased gamma-glutamyltransferase (3%)
Dose reductions of ELAHERE due to an AE occurred in 20% of patients1
- AEs which required dose reductions in ≥3% of patients included blurred vision (9%) and keratopathy (7%)
The median duration of treatment was 4.2 months (range: 0.7 to 13.3)1
‡One additional patient entered the study with Grade 1 alopecia. Alopecia was not a result of ELAHERE and grade did not change during treatment.2
Laboratory abnormalities in SORAYA1
Select laboratory abnormalities ≥10% for all grades or ≥2% for Grades 3-4 in patients who received ELAHERE
Laboratory abnormality
ELAHEREa
All Grades (%) | Grades 3-4 (%) | |
---|---|---|
Increased AST | 50 | 2 |
Increased ALT | 39 | 2 |
Increased alkaline phosphatase | 30 | 1 |
All Grades (%) | Grades 3-4 (%) | |
---|---|---|
Decreased lymphocytes | 35 | 7 |
Decreased leukocytes | 26 | 1 |
Decreased neutrophils | 26 | 3 |
Decreased hemoglobin | 25 | 3 |
Decreased platelets | 18 | 2 |
All Grades (%) | Grades 3-4 (%) | |
---|---|---|
Decreased albumin | 31 | 1 |
Decreased magnesium | 27 | 2 |
Increased creatinine | 16 | 0 |
Decreased potassium | 15 | 4 |
aThe denominator used to calculate the rate varied from 98 to 101 based on the number of patients with a baseline value and at least one posttreatment value.
Find out how ELAHERE is dosed and administered
Learn About DosingHow to Test for FRα
Testing for FRα is carried out at labs that have been validated to perform the VENTANA FOLR1 IHC assay.
How to Order ELAHERE
Please contact your participating specialty distributor or specialty pharmacy partners listed in the ELAHERE Ordering Information Sheet.
AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BCVA=best corrected visual acuity; FOLR1=folate receptor 1; FRα=folate receptor alpha; IC=investigator’s choice; IHC=immunohistochemistry.