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A

Indication details

Combined Agent(s)
Platinum-doublet ChT
Control Arm
Platinum-doublet ChT
Therapeutic Indication
Treatment of adult patients with resectable non-small cell lung cancer in the neoadjuvant setting
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Stage
Neoadjuvant
Trial Name
CHECKMATE-816
NCT Number
NCT02998528
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval March 2022
EMA Approval
EMA (CHMP) May 2023 EC decision July 2023
Comment
EMA approval is limited to patients whose tumours express PD-L1 on ≥1% of tumour cells. This approval was based on an analysis that does not meet the ESMO-MCBS requirements for subgroups (i.e. many subgroups and without adjustment) and so cannot be scored. Data shown are therefore from the overall population across all PD-L1 categories.

Primary Outcome(s)

Primary Outcome(s)
co-primary EFS, pCR
Evaluated Outcome
EFS
Form(s)
Form 1

Outcome Data

OS HR
Not mature
pCR Control
2.2%
pCR Gain
21.8%
EFS control
20.8 months - 2-year 45.3%
EFS gain
20.8 months - 2-year 45.3%
EFS HR
0.63 (97.38% CI, 0.43-0.91)

Final Score (after adjustments)

Final curative score

A

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
340
Scorecard version
1
Issue date
30.05.2022
Last update
15.11.2023
Nivolumab CHECKMATE-816

PRELIMINARY SCORE

EFS

ADJUSTMENTS

Nivolumab CHECKMATE-816

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
Thoracic Malignancies
Treatment of adult patients with resectable non-small cell lung cancer in the neoadjuvant setting
Nivolumab + Platinum-doublet ChT
Platinum-doublet 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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