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3

Indication details

Control Arm
Single arm
FDA Therapeutic Indication
Patients with locally advanced or metastatic UC who are not eligible for any platinum-containing ChT
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Urothelial Carcinoma
Tumour Stage
Locally advanced or metastatic
Trial Name
KEYNOTE-052
NCT Number
NCT02335424
Trial Phase
Phase II

Approval details

FDA Approval
FDA accelerated approval May 2017 full approval August 2021
EMA Approval
Not EMA approved for tumours without confirmed PD-L1 CPS ≥10

Primary Outcome(s)

Primary Outcome(s)
ORR
Evaluated Outcome
ORR
Form(s)
Form 3

Outcome Data

PFS Control
2.5 months
ORR
28.9%
DoR
33.4 months

Adjustments

QoL Comment
QoL was not a prespecified endpoint

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Comment
FDA approved; not EMA approved for tumours without confirmed PD-L1 CPS ≥10

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
356
Scorecard version
1
Issue date
14.11.2022
Last update
21.12.2023
Pembrolizumab KEYNOTE-052

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Pembrolizumab KEYNOTE-052

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
Genitourinary Cancers
Patients with locally advanced or metastatic UC who are not eligible for any platinum-containing ChT
Pembrolizumab
Single arm

My watchlist

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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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