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Indication details

Control Arm
Single arm (Phase II)
Therapeutic Indication
For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Squamous Cell Carcinoma
Tumour Stage
Locally advanced or metastatic
Trial Name
R2810-ONC-1423/R2810-ONC-1540
NCT Number
NCT02383212/NCT02760498
Trial Phase
Phase II

Approval details

FDA Approval
FDA approval September 2018
EMA Approval
EMA (CHMP) April 2019 EC decision June 2019

Primary Outcome(s)

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

Outcome Data

PFS Control
Estimated median PFS of 18.4 months for all patients
pCR Control
2-year: 44.2%
ORR
46.1%
DoR
NR (95% CI 28.8 months-NE)

Adjustments

QoL Comment
QoL improved

Score (after adjustments)

Preliminary non-curative score

3

QoL adjustment
1+
Non-curative score

4

Comment
EMA (CHMP) April 2019 EC decision June 2019

FDA approval September 2018

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
360
Scorecard version
1
Issue date
22.11.2022
Last update
02.05.2024
Cemiplimab R2810-ONC-1423/R2810-ONC-1540

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Improved QoL
Cemiplimab R2810-ONC-1423/R2810-ONC-1540

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
4
Overall Response Rate / Duration of Response
Skin Cancers
For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation
Cemiplimab
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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