Trial Outcomes & Findings for Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (NCT NCT05041257)
NCT ID: NCT05041257
Last Updated: 2026-01-09
Results Overview
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Mirvetuximab Soravtansine
Participants received single-agent mirvetuximab soravtansine at 6 milligrams (mg)/kilogram (kg) adjusted by ideal body weight (AIBW) administered through intravenous (IV) infusion on Day 1 of every 3-week cycle.
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|---|---|
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Overall Study
STARTED
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79
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Overall Study
Received at Least 1 Dose of Study Drug
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79
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Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
|
79
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Reasons for withdrawal
| Measure |
Mirvetuximab Soravtansine
Participants received single-agent mirvetuximab soravtansine at 6 milligrams (mg)/kilogram (kg) adjusted by ideal body weight (AIBW) administered through intravenous (IV) infusion on Day 1 of every 3-week cycle.
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|---|---|
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Overall Study
Death
|
37
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Overall Study
Lost to Follow-up
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3
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Overall Study
Sponsor decision
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39
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Baseline Characteristics
Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers
Baseline characteristics by cohort
| Measure |
Mirvetuximab Soravtansine
n=79 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
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Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.16 • n=9 Participants
|
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Sex: Female, Male
Female
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79 Participants
n=9 Participants
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Sex: Female, Male
Male
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0 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=9 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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68 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
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65 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator.
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=79 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Objective Response Rate (ORR) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1])
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51.9 percentage of participants
Interval 40.4 to 63.3
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator. 'Overall number of participants analyzed' = participants with objective response.
DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=41 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Duration of Response (DOR) Assessed by the Investigator Using RECIST v1.1
|
8.25 months
Interval 5.55 to 10.78
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and does not necessarily had a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of Study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=79 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
78 Participants
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: CA-125 Response-Evaluable Population included all participants who received at least 1 dose of mirvetuximab soravtansine, whose pretreatment sample was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 post-baseline CA-125 evaluation.
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=47 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
|
74.5 percentage of participants
Interval 59.7 to 86.1
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator.
PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=79 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
|
6.93 months
Interval 5.85 to 9.59
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Efficacy Evaluable Population Per Investigator included all participants who received at least 1 dose of mirvetuximab soravtansine and had measurable disease at baseline per Investigator.
Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Mirvetuximab Soravtansine
n=79 Participants
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Overall Survival Assessed by the Investigator Using RECIST v1.1
|
27.17 months
Interval 23.79 to
Due to insufficient number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.
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Adverse Events
Mirvetuximab Soravtansine
Serious events: 17 serious events
Other events: 77 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Mirvetuximab Soravtansine
n=79 participants at risk
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
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Eye disorders
KERATITIS
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
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Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.3%
1/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Gastrointestinal disorders
SUBILEUS
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1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Gastrointestinal disorders
VOMITING
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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General disorders
EXTRAVASATION
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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General disorders
SUPRAPUBIC PAIN
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Infections and infestations
CYSTITIS
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Infections and infestations
PNEUMONIA
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Infections and infestations
PYELONEPHRITIS
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Infections and infestations
SEPTIC SHOCK
|
1.3%
1/79 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Nervous system disorders
ATAXIA
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Nervous system disorders
NEUROPATHY PERIPHERAL
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Nervous system disorders
SYNCOPE
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Nervous system disorders
THROMBOTIC STROKE
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
5.1%
4/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.3%
1/79 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
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Other adverse events
| Measure |
Mirvetuximab Soravtansine
n=79 participants at risk
Participants received single-agent mirvetuximab soravtansine at 6 mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle.
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|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
7.6%
6/79 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
17.7%
14/79 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.7%
14/79 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
DIARRHOEA
|
30.4%
24/79 • Number of events 46 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
FLATULENCE
|
5.1%
4/79 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
NAUSEA
|
36.7%
29/79 • Number of events 42 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
STOMATITIS
|
6.3%
5/79 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Gastrointestinal disorders
VOMITING
|
17.7%
14/79 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
General disorders
ASTHENIA
|
30.4%
24/79 • Number of events 40 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
General disorders
FATIGUE
|
17.7%
14/79 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
General disorders
PYREXIA
|
10.1%
8/79 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Infections and infestations
COVID-19
|
16.5%
13/79 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
19.0%
15/79 • Number of events 23 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
21.5%
17/79 • Number of events 25 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
8.9%
7/79 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.1%
4/79 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Investigations
WEIGHT DECREASED
|
6.3%
5/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
8.9%
7/79 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
EYE PAIN
|
6.3%
5/79 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
KERATITIS
|
7.6%
6/79 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
KERATOPATHY
|
32.9%
26/79 • Number of events 57 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
PHOTOPHOBIA
|
16.5%
13/79 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
VISION BLURRED
|
65.8%
52/79 • Number of events 116 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
8.9%
7/79 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
VITREOUS FLOATERS
|
7.6%
6/79 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.9%
7/79 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
13.9%
11/79 • Number of events 34 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
6.3%
5/79 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
CATARACT
|
34.2%
27/79 • Number of events 41 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
CORNEAL EPITHELIAL MICROCYSTS
|
6.3%
5/79 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Eye disorders
DRY EYE
|
40.5%
32/79 • Number of events 49 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.1%
8/79 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
11.4%
9/79 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.3%
5/79 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
24.1%
19/79 • Number of events 24 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.1%
4/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.9%
7/79 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.6%
6/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
DIZZINESS
|
5.1%
4/79 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
DYSGEUSIA
|
11.4%
9/79 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
HEADACHE
|
16.5%
13/79 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
27.8%
22/79 • Number of events 37 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
NEUROTOXICITY
|
12.7%
10/79 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
PARAESTHESIA
|
6.3%
5/79 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
8.9%
7/79 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Psychiatric disorders
ANXIETY
|
5.1%
4/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Psychiatric disorders
INSOMNIA
|
6.3%
5/79 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.6%
6/79 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.1%
8/79 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
7.6%
6/79 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.1%
4/79 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
|
Vascular disorders
HYPERTENSION
|
5.1%
4/79 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 26.5 months.
Safety Population included all participants who received at least 1 dose of mirvetuximab soravtansine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER