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3

Indication details

Combined Agent(s)
Gemcitabine
Control Arm
Gemcitabine
Treatment setting
Nab-paclitaxel in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Pancreatic cancer
Tumour Stage
Metastatic
Trial Name
MPACT
NCT Number
NCT00844649
Trial Phase
Phase III

Approval details

FDA Approval
FDA approved September 2013
EMA Approval
EMA approved November 2013

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
6.6 months
OS Gain
2.1 months
OS HR
0.72 (0.62-0.83)

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
34
Scorecard version
1
Issue date
11.12.2018
Last update
19.07.2023
Nab-paclitaxel MPACT

PRELIMINARY SCORE

OS

ADJUSTMENTS

Nab-paclitaxel MPACT

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
3
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Gastrointestinal Cancers
Nab-paclitaxel in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas
Nab-paclitaxel + Gemcitabine
Gemcitabine

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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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