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3

Indication details

Control Arm
Single arm
FDA Therapeutic Indication
Treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Stage
Advanced
Tumour Sub-Group
RET fusion-positive
Trial Name
LIBRETTO-001
NCT Number
NCT03157128
Trial Phase
Phase I/II

Approval details

FDA Approval
FDA accelerated approval May 2020
EMA Approval
EMA (CHMP) April 2022 EC decision June 2022

Primary Outcome(s)

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

Outcome Data

PFS Control
22.0 months
ORR
84%
DoR
20.2 months

Adjustments

QoL Comment
QoL evaluated as an exploratory endpoint

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
341
Scorecard version
1
Issue date
31.05.2022
Last update
16.08.2023
Selpercatinib LIBRETTO-001

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Selpercatinib LIBRETTO-001

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
3
Overall Response Rate / Duration of Response
Thoracic Malignancies
Treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
Selpercatinib
Single arm

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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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