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3

Indication details

Control Arm
Sunitinib
Therapeutic Indication
First-line treatment of adult patients with intermediate or poor risk advanced RCC
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Renal cell cancer
Tumour Stage
Intermediate or poor risk
Trial Name
CABOSUN
NCT Number
NCT01835158
Trial Phase
Phase II

Approval details

FDA Approval
FDA approval December 2017
EMA Approval
EMA (CHMP) February 2021 EC Decision April 2021

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
5.6 months
PFS Gain
2.6 months
PFS HR
0.66 (0.46-0.95)
OS Control
21.2 months
OS Gain
5.4 months
OS HR
0.80 (0.53-1.21) not significant (immature)

Adjustments

QoL Comment
QoL was not a prespecified endpoint

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
255
Scorecard version
1
Issue date
29.03.2021
Last update
15.05.2023
Cabozantinib CABOSUN

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Cabozantinib CABOSUN

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
3
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Genitourinary Cancers
First-line treatment of adult patients with intermediate or poor risk advanced RCC
Cabozantinib
Sunitinib

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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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