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3

Indication details

Combined Agent(s)
Cobimetinib and vemurafenib
Control Arm
Placebo
Therapeutic Indication
Treatment for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Melanoma
Tumour Stage
Unresectable or metastatic
Tumour Sub-Group
BRAF V600
Trial Name
IMspire150
NCT Number
NCT02908672
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval July 2020

Primary Outcome(s)

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

Outcome Data

PFS Control
10.6 months
PFS Gain
4.5 months
PFS HR
0.78 (0.63-0.97)
OS Control
2-year survival 53%
OS Gain
2-year survival 7%
OS HR
NS (immature)

Adjustments

QoL Comment
QoL data pending

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
232
Scorecard version
1
Issue date
5.11.2020
Atezolizumab IMspire150

PRELIMINARY SCORE

PFS

ADJUSTMENTS

?
QoL data pending
Atezolizumab IMspire150

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
Skin Cancers
Treatment for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Atezolizumab + Cobimetinib and vemurafenib
Placebo

My watchlist

    pdf
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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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