Drug Trial Snapshots: ELAHERE
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ELAHERE Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
ELAHERE (mirvetuximab soravtansine-gynx)
(el-ah-HERE)
ImmunoGen, Inc.
Approval date: Month November 14, 2022
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ELAHERE is a prescription drug used for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatments.
How is this drug used?
ELAHERE is given into a vein (intravenous infusion) by a healthcare professional once every three weeks.
Who participated in the clinical trials?
The FDA approved ELAHERE based on evidence from one clinical trial of 106 patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT04296890). The trial was conducted at 39 sites in 8 countries in North America, Europe, and Asia Pacific.
How were the trials designed?
The benefits and side effects of ELAHERE were evaluated in one clinical trial of 106 patients with FRα positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who had received one to three prior systemic treatments.
How were the trials designed?
There was one multicenter, single-arm, trial that enrolled patients with FRα positive, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who had received one to three prior systemic treatments.
Patients received ELAHERE 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. Tumor imaging was obtained every 6 weeks for the first 36 weeks and every 12 weeks thereafter.
Major efficacy outcome measures were investigator assessed overall response rate using RECIST 1.1 and duration of response.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarize the percentage of patients by sex enrolled in the clinical trial used to evaluate the safety and efficacy of ELAHERE.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Review
Figure 2 summarize the percentage of patients by race enrolled in the clinical trial used to evaluate the safety and efficacy of ELAHERE.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Review
Figure 3 summarizes the percentage of patients by age in the clinical trial.
Figure 3. Baseline Demographics by Age
Source: Adapted from FDA Review
Who participated in the trials?
Table 6. Baseline Demographics of Patients in the Clinical Trial (Safety Population)
| Demographic | All Patients N=106 n (%) |
|---|---|
| Age, years | |
| Mean (SD) | 62 (10) |
| Median (min, max) | 62 (35, 85) |
| Age group | |
| 18 to <65 | 59 (56) |
| ≥65 | 47 (44) |
| Sex | |
| Female | 106 (100) |
| Ethnicity | |
| Hispanic or Latino | 2 (2) |
| Not Hispanic or Latino | 99 (93) |
| Not Reported | 4 (4) |
| Unknown | 1 (1) |
| Race | |
| White | 102 (96) |
| Asian | 2 (2) |
| Not reported | 2 (2) |
| Region | |
| United States | 24 (23) |
| Europe | 71 (67) |
| Australia | 11 (10) |
What are the benefits of this drug?
The trial measured the percent of patients whose tumors completely or partially shrank after treatment (overall response rate). In the trial, approximately 32% of 104 patients taking ELAHERE experienced complete or partial shrinkage of their tumors, which lasted an average of 7 months.
ELAHERE was approved under FDA’s accelerated approval program. This program lets patients take a promising new drug while the company continues clinical trials to confirm that the drug works well.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 1 shows efficacy results based on investigator assessed overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. and duration of response. Response assessment results using independent radiology review were consistent with investigator assessment.
Table 1. Efficacy Results for Study 0417
| Parameter | ELAHERE N=104 |
|---|---|
| Confirmed overall response ratea (95% CI) | 31.7% (22.9, 41.6) |
| Complete response rate | 4.8% |
| Partial response rate | 26.9% |
| Duration of response | N=33 |
| Median duration of response, months (95% CI) | 6.9 (5.6, 9.7) |
Source: ELAHERE Prescribing Information
a Investigator assessment
Abbreviations: CI, confidence interval
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: All the patients in the trial were female, therefore only race and age differences were analyzed.
- Race: The number of patients of races other than White was small; therefore, differences in how ELAHERE worked among races could not be determined
- Age: ELAHERE worked similarly in patients younger and older than 65 years of age.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 2 summarizes efficacy results by age group based on the overall response rate.
Table 2. Subgroup Analysis of Confirmed Overall Response Rate per Investigator by Age
| Overall Response Rate | Number of Patients | Number of Responders | ORR (%) 95% CI |
|---|---|---|---|
| Overall | 104 | 33 | 31.7 (22.9, 41.6) |
| Age, years | |||
| <65 | 59 | 20 | 33.9 (22.1, 47.4) |
| ≥65 | 45 | 13 | 28.9 (16.4, 44.3) |
Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; ORR, overall response rate
What are the possible side effects?
Eye problems are common with ELAHERE and can also be severe. The eye problems may include blurred vision, dry eyes, sensitivity to light, eye pain, or new or worsening vision changes.
ELAHERE can cause serious side effects including lung problems (pneumonitis), nerve problems called peripheral neuropathy, or harm to an unborn baby.
The most common side effects of ELAHERE include feeling tired, vision impairment, increased liver enzymes in the blood, nausea, stomach-area (abdominal) pain, decreased red or white blood cell counts, peripheral neuropathy, diarrhea, decreased albumin level in the blood, constipation, dry eye, and decreased magnesium level in the blood.
What are the possible side effects (results of trials used to assess safety)?
Table 3 summarizes the adverse reactions that occurred in the clinical trial.
Table 3. Adverse Reactions (≥10%) in Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Received ELAHERE in Study 0417
| Adverse Reaction | All Grades N=106 % |
Grade 3 or 4 N=106 % |
|---|---|---|
| Eye disorders | ||
| Vision impairment1 | 50 | 7 |
| Keratopathy2 | 37 | 9 |
| Dry eye3 | 27 | 2 |
| Cataract | 18 | 3 |
| Photophobia | 17 | 0 |
| Eye pain4 | 10 | 0 |
| General disorders | ||
| Fatigue5 | 49 | 3 |
| Gastrointestinal disorders | ||
| Nausea | 40 | 0 |
| Abdominal pain6 | 36 | 7 |
| Diarrhea | 31 | 3 |
| Constipation | 30 | 1 |
| Vomiting | 19 | 0 |
| Abdominal distension | 11 | 0 |
| Nervous system disorders | ||
| Peripheral neuropathy7 | 33 | 2 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 18 | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 17 | 0 |
| Myalgia | 10 | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Dyspnea8 | 12 | 0 |
Source: Adapted from ELAHERE Prescribing Information.
1Visual impairment includes vision blurred, vitreous floaters, visual acuity reduced, diplopia, presbyopia, accommodation disorder, visual impairment, and refraction disorder
2Keratopathy includes corneal disorder, corneal epithelial microcysts, corneal epithelial defect, keratitis, keratopathy, corneal deposits, and punctate keratitis
3Dry eye includes dry eye and lacrimation increased
4Eye pain includes eye pain and ocular discomfort
5Fatigue includes fatigue and asthenia
6Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort
7Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, hypoesthesia, polyneuropathy, and neurotoxicity
8Dyspnea includes dyspnea and exertional dyspnea
Were there any differences in side effects among sex, race and age?
- Sex: Everyone in the trial was female, therefore sex differences could not be determined.
- Race: The number of patients of races other than White was small; therefore, differences in the occurrence of side effects among races could not be determined.
- Age: The occurrence of severe side effects was similar in patients younger and older than 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 4 summarizes adverse reactions during the clinical trial by age subgroup.
Table 4. Summary of Adverse Reactions by Age
| Adverse Reaction | Age, Years | |
|---|---|---|
| <65 N=59 n (%) |
≥65 N=47 n (%) |
|
| All ARs | 59 (100) | 47 (100) |
| Grade ≥3 ARs | 30 (50) | 23 (49) |
| Serious ARs | 22 (37) | 14 (30) |
Source: Adapted from FDA Review
Abbreviations: AR, adverse reaction
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.