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3

Indication details

Control Arm
Single arm (Phase I/II)
Therapeutic Indication
EMA/FDA: Treatment for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options (other than non-small cell lung cancer and thyroid cancer).
Tumour Stage
Locally advanced or metastatic
Trial Name
LIBRETTO-001
NCT Number
NCT03157128
Trial Phase
Phase I/II

Approval details

FDA Approval
FDA accelerated approval September 2022
EMA Approval
EMA (CHMP) March 2024. Pending EC decision (recommendations on extensions)

Primary Outcome(s)

Primary Outcome(s)
ORR
Evaluated Outcome
ORR Overall study population
Form(s)
Form 3

Outcome Data

PFS Control
13.2 months
ORR
43.9%
DoR
24.5 months

Adjustments

QoL Comment
QoL was not a prespecified endpoint
Toxicity Comment
14/45 patients (31%) experience grade 3-5 AEs impacting on daily well being

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
357
Scorecard version
1
Issue date
14.11.2022
Last update
26.03.2024
Selpercatinib LIBRETTO-001

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Selpercatinib LIBRETTO-001

FINAL 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
EMA/FDA: Treatment for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options (other than non-small cell lung cancer and thyroid cancer).
Selpercatinib
Single arm (Phase I/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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