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3

Indication details

Combined Agent(s)
Bevacizumab, paclitaxel and carboplatin
Control Arm
Bevacizumab, paclitaxel and carboplatin
Therapeutic Indication
In patients with EGFR mutant or ALK-positive NSCLC, atezolizumab, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Stage
Metastatic
Tumour Sub-Group
EGFR+ or ALK-positive
Trial Name
IMpower150
NCT Number
NCT02366143
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval December 2018
EMA Approval
EMA (CHMP) January 2019 EC decision March 2019

Primary Outcome(s)

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

Outcome Data

PFS Control
6.1 months
PFS Gain
3.1 months
PFS HR
0.59 (0.37–0.94)

Adjustments

Toxicity Comment
Similar toxicity

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
156
Scorecard version
1
Issue date
16.03.2020
Last update
16.08.2023
Atezolizumab IMpower150

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Atezolizumab IMpower150

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
Thoracic Malignancies
In patients with EGFR mutant or ALK-positive NSCLC, atezolizumab, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies
Atezolizumab + Bevacizumab, paclitaxel and carboplatin
Bevacizumab, paclitaxel and carboplatin

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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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