4
Indication details
- Combined Agent(s)
- Paclitaxel + cisplatin
- Control Arm
- Placebo + paclitaxel + cisplatin
- Therapeutic Indication
- Toripalimab, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal squamous cell carcinoma
- Tumour Stage
- Unresectable advanced, recurrent or metastatic
- Trial Name
- JUPITER-06
- NCT Number
- NCT03829969
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) approved July 2024. EC decision September 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.5 months
- PFS Gain
- 0.2 months
- PFS HR
- 0.58 (0.46-0.74)
- OS Control
- 11 months
- OS Gain
- 6 months
- OS HR
- 0.58 (0.43-0.78). ITT. Interim analysis, cut-off date of March 22, 2021
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 455
- Issue date
- 12.09.2024
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.