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4

Indication details

Combined Agent(s)
Durvalumab and platinum-based ChT
Control Arm
Platinum-based ChT
Therapeutic Indication
EMA: First-line treatment of tremelimumab in combination with durvalumab and platinum-based chemotherapy (ChT) for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations - FDA: Tremelimumab in combination with durvalumab and platinum-based ChT for adult patients with metastatic NSCLC with no EGFR mutation or ALK genomic tumor aberrations.
Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Stage
Metastatic
Trial Name
POSEIDON
NCT Number
NCT03164616
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval November 2022
EMA Approval
EMA (CHMP) December 2022 EC decision April 2023

Primary Outcome(s)

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

Outcome Data

PFS Control
4.8 months
PFS Gain
1.4 months
PFS HR
0.72 (0.60-0.86)
OS Control
11.7 months
OS Gain
2.3 months 2-year survival gain 10.8%
OS HR
0.77 (0.65-0.92)

Adjustments

QoL Comment
QoL data pending

Final Score (after adjustments)

Preliminary non-curative score

4

Final non-curative score

4

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
362
Scorecard version
1
Issue date
01.12.2022
Last update
26.06.2023
Tremelimumab POSEIDON

PRELIMINARY SCORE

OS

ADJUSTMENTS

?
QoL data pending
Tremelimumab POSEIDON

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
4
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
EMA: First-line treatment of tremelimumab in combination with durvalumab and platinum-based chemotherapy (ChT) for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations - FDA: Tremelimumab in combination with durvalumab and platinum-based ChT for adult patients with metastatic NSCLC with no EGFR mutation or ALK genomic tumor aberrations.
Tremelimumab + Durvalumab and platinum-based ChT
Platinum-based 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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