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3

Indication details

Control Arm
Single arm (Phase II)
FDA Therapeutic Indication
For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options
Tumour Type
Brain Tumours
Tumour Sub-type
Glioma (low grade)
Tumour Stage
Unresectable or metastatic
Tumour Sub-Group
BRAF V600E
Trial Name
ROAR
NCT Number
NCT02034110
Trial Phase
Phase II

Approval details

FDA Approval
FDA accelerated approval June 2022

Primary Outcome(s)

Primary Outcome(s)
Investigator-assessed ORR
Evaluated Outcome
ORR
Form(s)
Form 3

Outcome Data

PFS Control
>7.4 months
ORR
69%
DoR
Not reached (27.5 months by independent radiology review)

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Comment
FDA accelerated approval June 2022

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
347
Scorecard version
1
Issue date
07.09.2022
Dab/Tram (dabrafenib and trametinib) ROAR

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Dab/Tram (dabrafenib and trametinib) ROAR

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
3
Overall Response Rate / Duration of Response
Brain Tumours
For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options
Dab/Tram (dabrafenib and trametinib)
Single arm (Phase II)

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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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