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4

Indication details

Combined Agent(s)
Gemcitabine and cisplatin
Control Arm
Placebo + gemcitabine and cisplatin
FDA Therapeutic Indication
Durvalumab in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Biliary tract cancer
Tumour Stage
Unresectable or metastatic
Trial Name
TOPAZ-1
NCT Number
NCT03875235
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval September 2022
EMA Approval
EMA (CHMP) approved November 2022. EC decision January 2023
Comment
FDA approval for first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).

Primary Outcome(s)

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

Outcome Data

PFS Control
5.7 months
PFS Gain
1.5 months
PFS HR
0.75 (0.63-0.89)
OS Control
11.3 months
OS Gain
1.6 months (12.1% 2-year OS gain) The 2-year OS gain reported was based on 36 patients (10.6% of the experimental group) who were still alive at that time.
OS HR
0.76 (0.64-0.91)

Adjustments

QoL Comment
No QoL benefit

Score (after adjustments)

Preliminary non-curative score

4

Non-curative score

4

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
350
Scorecard version
1
Issue date
22.09.2022
Last update
11.10.2024
Durvalumab TOPAZ-1

PRELIMINARY SCORE

OS

ADJUSTMENTS

No QoL benefit
Durvalumab TOPAZ-1

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
Gastrointestinal Cancers
Durvalumab in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer
Durvalumab + Gemcitabine and cisplatin
Placebo + gemcitabine and cisplatin

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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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