Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

3

Indication details

Combined Agent(s)
Platinum + fluoropyrimidine-based ChT
Control Arm
Placebo + platinum + fluoropyrimidine-based ChT
Therapeutic Indication
Tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD‑L1 with a tumour area positivity (TAP) score ≥ 5%
Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Gastric or gastroesophageal junction adenocarcinoma
Tumour Stage
Locally advanced unresectable or metastatic
Tumour Sub-Group
HER2- , PD-L1 TAP ≥5%
Trial Name
RATIONALE 305
NCT Number
NCT03777657
Trial Phase
Phase III

Approval details

EMA Approval
EMA (CHMP) October 2024. EC decision November 2024

Primary Outcome(s)

Primary Outcome(s)
OS (PD-L1 TAP ≥5%)
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
12.8 months
OS Gain
3.6 months
OS HR
0.71 (0.58-0.86)

Adjustments

QoL Comment
QoL data pending

Score (after adjustments)

Preliminary non-curative score

3

Non-curative score

3

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
466
Scorecard version
1
Issue date
22.10.2024
Tislelizumab RATIONALE 305

PRELIMINARY SCORE

OS

ADJUSTMENTS

?
QoL data pending
Tislelizumab RATIONALE 305

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
3
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
Tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD‑L1 with a tumour area positivity (TAP) score ≥ 5%
Tislelizumab + Platinum + fluoropyrimidine-based ChT
Placebo + platinum + fluoropyrimidine-based ChT

My watchlist

    pdf
    pptx

    Legend

    Information about symbols, abbrevations and color codes

    This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

    For more detailed information on the cookies we use, please check our Privacy Policy.

    Customise settings
    • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.

    • Analytics cookies help us improve our website by collecting and reporting information on its usage.

    • We use marketing cookies to build a profile of you as a user through your actions on our site in order to better understand your interests and provide you with pertinent suggestions.