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2

Indication details

Control Arm
Single arm (Phase II)
FDA Therapeutic Indication
Adult patients with recurrent or metastatic cervical cancer with disease progression on or after ChT
Tumour Type
Gynaecological Malignancies
Tumour Sub-type
Cervical Cancer
Tumour Stage
Recurrent or metastatic
Trial Name
innovaTV 204
NCT Number
NCT03438396
Trial Phase
Phase II

Approval details

FDA Approval
FDA accelerated approval September 2021
Comment
FDA traditional approval April 2024 on trial innovaTV301

Primary Outcome(s)

Primary Outcome(s)
ORR
Evaluated Outcome
ORR
Form(s)
Form 3

Outcome Data

PFS Control
4.2 months
ORR
24%
DoR
8.3 months

Score (after adjustments)

Preliminary non-curative score

2

Non-curative score

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
299
Scorecard version
1
Issue date
25.10.2021
Tisotumab vedotin innovaTV 204

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Tisotumab vedotin innovaTV 204

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
2
Overall Response Rate / Duration of Response
Gynaecological Malignancies
Adult patients with recurrent or metastatic cervical cancer with disease progression on or after ChT
Tisotumab vedotin
Single arm (Phase II)

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    Legend

    Information about symbols, abbrevations and color codes

    Red = negative
    Green = positive
    Grey = neutral
    ? Grey + ? = neutral with pending data
    DFS
    Disease-Free Survival
    DoR
    Duration of Response
    EFS
    Event-Free Survival
    HR
    Hazard Ratio
    NEB
    No evaluable benefit
    NI
    Non-inferiority Study
    ORR
    Overall Response Rate
    OS
    Overall Surival
    pCR
    Pathological Complete Response/Remission
    PFS
    Progression-Free Survival
    QoL
    Quality of Life
    RFS
    Relapse-Free Survival
    RR
    Response Rate

    QoL adjustments

    Other adjustments*

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    QoL adjustments

    Red = negative / deterioration

    Green = positive / improvement

    Other adjustments*

    Red = negative / deterioration

    Green = positive / improvement

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    * Other adjustments include:

    - Long-term plateau in the survival curve
    - Long-term plateau in the PFS curve
    - Early stopping or crossover
    - Only improved PFS mature data shows no OS advantage and no improved Qol.

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