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
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.