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NCT01609556 · OUTCOME

Time to Progression (TTP) as Assessed by RECIST v1.1

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors · Source last updated 2021-02-17

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)

What was measured

TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. 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.

Analysis population: Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.

Groups in this outcome

Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)

Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)

Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)

Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)

Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)43
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)24
Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)113
Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)2.7Not reported1.33.3Not reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)3.9Not reported1.811.1Not reported
Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)4.4Not reported4.05.6Not reported
Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)2.8Not reported1.26.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.3
        upper Limit
        3.3
        value
        2.7
      2. group Id
        OG001
        lower Limit
        1.8
        upper Limit
        11.1
        value
        3.9
      3. group Id
        OG002
        lower Limit
        4.0
        upper Limit
        5.6
        value
        4.4
      4. group Id
        OG003
        lower Limit
        1.2
        upper Limit
        6.9
        value
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      113
    4. group Id
      OG003
      value
      24
    units
    Participants
description
TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. 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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG000
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
  2. description
    Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG001
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
  3. description
    Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG002
    title
    Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)
  4. description
    Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG003
    title
    Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
param Type
MEDIAN
population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
reporting Status
POSTED
time Frame
From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
title
Time to Progression (TTP) as Assessed by RECIST v1.1
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice