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3

Indication details

Combined Agent(s)
Fluoropyrimidine and platinum-based combination ChT
Control Arm
ChT
Therapeutic Indication
First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with fluoropyrimidine and platinum-based combination ChT
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Oesophageal Cancer
Tumour Stage
Advanced or metastatic
Trial Name
CheckMate 648
NCT Number
NCT03143153
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval May 2022
Comment
FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.

Primary Outcome(s)

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

Outcome Data

OS Control
10.7 months
OS Gain
2.5 months
OS HR
0.74 (99.1% CI 0.58-0.96)

Final Score (after adjustments)

Preliminary non-curative score

3

Final non-curative score

3

Comment
FDA approval May 2022

FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
344
Scorecard version
1
Issue date
07.09.2022
Nivolumab CheckMate 648

PRELIMINARY SCORE

OS

ADJUSTMENTS

Nivolumab CheckMate 648

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
Gastrointestinal Cancers
First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with fluoropyrimidine and platinum-based combination ChT
Nivolumab + Fluoropyrimidine and platinum-based combination ChT
ChT

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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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