Trial Outcomes & Findings for A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression (NCT NCT04209855)

NCT ID: NCT04209855

Last Updated: 2025-08-27

Results Overview

PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (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 millimeters (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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

453 participants

Primary outcome timeframe

From randomization until PD or death, whichever occurred first (up to approximately 36 months)

Results posted on

2025-08-27

Participant Flow

A total of 453 participants were randomized to a treatment group and included in the Intent-to-Treat (ITT) population. 425 participants received at least 1 dose of study drug and were included in the Safety Population.

Participant milestones

Participant milestones
Measure	Mirvetuximab Soravtansine Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).	Investigator's Choice (IC) Chemotherapy Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Overall Study STARTED	227	226
Overall Study Received at Least 1 Dose of Study Drug	218	207
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	227	226

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirvetuximab Soravtansine Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).	Investigator's Choice (IC) Chemotherapy Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Overall Study Death	161	177
Overall Study PI Discretion	1	1
Overall Study Lost to Follow-up	5	2
Overall Study Withdrew consent	10	24
Overall Study Sponsor decision	44	18
Overall Study Other than specified	6	4

Baseline Characteristics

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirvetuximab Soravtansine n=227 Participants Participants received single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=226 Participants Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.	Total n=453 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 9.85 • n=93 Participants	62.3 years STANDARD_DEVIATION 9.30 • n=4 Participants	62.8 years STANDARD_DEVIATION 9.58 • n=27 Participants
Sex: Female, Male Female	227 Participants n=93 Participants	226 Participants n=4 Participants	453 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	177 Participants n=93 Participants	163 Participants n=4 Participants	340 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	38 Participants n=93 Participants	48 Participants n=4 Participants	86 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	28 Participants n=93 Participants	25 Participants n=4 Participants	53 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	156 Participants n=93 Participants	145 Participants n=4 Participants	301 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants n=93 Participants	51 Participants n=4 Participants	86 Participants n=27 Participants

PRIMARY outcome

Timeframe: From randomization until PD or death, whichever occurred first (up to approximately 36 months)

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=227 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=226 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	5.59 months Interval 4.34 to 5.88	3.98 months Interval 2.86 to 4.47

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).

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 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

Outcome measures
Measure	Mirvetuximab Soravtansine n=227 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=226 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1	41.9 percentage of participants Interval 35.4 to 48.6	15.9 percentage of participants Interval 11.4 to 21.4

SECONDARY outcome

Timeframe: Up to approximately 45 months

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).

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

Outcome measures
Measure	Mirvetuximab Soravtansine n=227 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=226 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Overall Survival Assessed by the Investigator Using RECIST v1.1	16.85 months Interval 14.36 to 19.78	13.34 months Interval 11.37 to 15.15

SECONDARY outcome

Timeframe: Baseline and Week 8 or 9

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=162 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=150 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)	34 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: The Safety Population included all participants who received at least one dose of study treatment.

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 did not necessarily have 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 serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=218 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=207 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	211 Participants	194 Participants

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, "Overall number of participants analyzed" is the number of evaluable participants for this outcome measure who had CR or PR.

DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are 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 have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=95 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=36 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1	6.93 months Interval 5.78 to 8.84	4.44 months Interval 4.17 to 5.75

SECONDARY outcome

Timeframe: Baseline up to approximately 36 months

Population: The CA-125-Evaluable Population included all randomized participants who received at least 1 dose of MIRV or IC Chemo, whose pretreatment CA-125 was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, 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

Outcome measures
Measure	Mirvetuximab Soravtansine n=181 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=156 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria	58.0 percentage of participants Interval 50.5 to 65.3	30.1 percentage of participants Interval 23.1 to 38.0

SECONDARY outcome

Timeframe: Up to approximately 44 months

Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).

PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=227 Participants Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.	Investigator's Choice (IC) Chemotherapy n=226 Participants Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
Time to Second Progression-Free Survival (PFS 2)	11.01 months Interval 9.3 to 12.02	7.59 months Interval 6.6 to 8.84

Adverse Events

Mirvetuximab Soravtansine

Serious events: 62 serious events

Other events: 212 other events

Deaths: 162 deaths

Investigator's Choice (IC) Chemotherapy

Serious events: 73 serious events

Other events: 196 other events

Deaths: 177 deaths

Serious adverse events

Other adverse events

Additional Information

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Email: [email protected]

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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.
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