Participant flow

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 · Source last updated 2025-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   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).

   id

   FG000

   title

   Mirvetuximab Soravtansine

2. description

   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.

   id

   FG001

   title

   Investigator's Choice (IC) Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         161

      2. group Id

         FG001

         num Subjects

         177

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      PI Discretion

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         24

      type

      Withdrew consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         18

      type

      Sponsor decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Other than specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         226

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         218

      2. group Id

         FG001

         num Subjects

         207

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Still on treatment

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         226

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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.

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Preserved source evidence · Not medical advice