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3

Indication details

Control Arm
 Subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF)
Therapeutic Indication
EMA: Indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. FDA: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Melanoma
Tumour Stage
Unresectable that is regionally or distantly metastatic
Trial Name
OPTiM
NCT Number
NCT00769704
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval October 2015
EMA Approval
EMA (CHMP) October 2015 EC decision December 2015

Primary Outcome(s)

Primary Outcome(s)
DRR (lasting continuously 6 months) per independent assessment
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
18.9 months
OS Gain
4.4 months
OS HR
0.79 (0.62-1.00), p=0.0494
RR Gain
6 month durable response rate 2.1%
ORR
DRR gain 14.2%

Adjustments

QoL Comment
QoL was not a prespecified endpoint

Final Score (after adjustments)

Final non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
378
Scorecard version
1
Issue date
08.05.2023
Talimogene Laherparepvec OPTiM

PRELIMINARY SCORE

OS

ADJUSTMENTS

Talimogene Laherparepvec OPTiM

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
Skin Cancers
EMA: Indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. FDA: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Talimogene Laherparepvec
 Subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF)

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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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