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A

Indication details

Control Arm
Placebo
Therapeutic Indication
Adjuvant therapy for adult patients with oesophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Oesophageal or gastroesophageal carcinoma
Tumour Stage
Adjuvant
Trial Name
CheckMate 577
NCT Number
NCT02743494
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval May 2021
EMA Approval
EMA (CHMP) June 2021 EC decision August 2021

Primary Outcome(s)

Primary Outcome(s)
DFS
Evaluated Outcome
DFS
Form(s)
Form 1

Outcome Data

DFS Control
11.0 months
DFS Gain
11.4 months
DFS HR
0.69 (96.4%CI 0.56-0.86)

Final Score (after adjustments)

Final curative score

A

Comment
EMA (CHMP) June 2021
EC decision August 2021
FDA approval May 2021

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
279
Scorecard version
1
Issue date
25.06.2021
Last update
05.07.2021
Nivolumab CheckMate 577

PRELIMINARY SCORE

DFS

ADJUSTMENTS

Nivolumab CheckMate 577

FINAL SCORE

A

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
Overall Response Rate / Duration of Response
Gastrointestinal Cancers
Adjuvant therapy for adult patients with oesophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
Nivolumab
Placebo

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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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