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3

Indication details

Control Arm
Sorafenib
Therapeutic Indication
Treatment of adult patients with advanced RCC after failure of prior treatment with sunitinib or cytokine
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Renal cell cancer
Tumour Stage
Advanced
Trial Name
AXIS
NCT Number
NCT00678392
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval January 2012
EMA Approval
EMA (CHMP) May 2012 EC decision July 2012

Primary Outcome(s)

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

Outcome Data

PFS Control
4.7 months
PFS Gain
2.0 months
PFS HR
0.67 (0.54-0.81)
OS Control
19.2 months
OS Gain
0.9 month
OS HR
0.969 (0800-1.174) Not significant (mature)

Adjustments

QoL Comment
No QoL benefit
Toxicity Comment
Less serious adverse events observed

Final Score (after adjustments)

Preliminary non-curative score

3

Only improved PFS mature data shows no OS advantage and no improved QoL
1-
Toxicity adjustment
1+
Final non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
104
Scorecard version
1
Issue date
11.12.2018
Last update
16.05.2023
Axitinib AXIS

PRELIMINARY SCORE

PFS

ADJUSTMENTS

No QoL benefit
Less serious adverse events observed
Only improved PFS mature data shows no OS advantage and no improved QoL
Axitinib AXIS

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
Treatment of adult patients with advanced RCC after failure of prior treatment with sunitinib or cytokine
Axitinib
Sorafenib

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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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