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3

Indication details

Combined Agent(s)
Carboplatin and etoposide
Control Arm
Placebo plus carboplatin and etoposide
FDA Therapeutic Indication
First-line treatment of extensive-stage SCLC
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Small-cell Lung Cancer
Tumour Stage
Extensive-stage
Trial Name
IMpower133
NCT Number
NCT02763579
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval March 2019
EMA Approval
EMA (CHMP) July 2019 EC decision September 2019

Primary Outcome(s)

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

Outcome Data

PFS Control
4.3 months
PFS Gain
0.9 months
PFS HR
0.77 (0.63-0.95)
OS Control
10.3 months
OS Gain
2.0 months
OS HR
0.76 (0.60-0.95)

Adjustments

QoL Comment
Benefit for delayed deterioration in global QoL not significant

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
194
Scorecard version
1
Issue date
17.07.2020
Last update
18.09.2023
Atezolizumab IMpower133

PRELIMINARY SCORE

OS

ADJUSTMENTS

No QoL benefit
Atezolizumab IMpower133

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
Thoracic Malignancies
First-line treatment of extensive-stage SCLC
Atezolizumab + Carboplatin and etoposide
Placebo plus carboplatin and etoposide

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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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