NEB
Indication details
- Control Arm
- ChT (vinflunine, paclitaxel or docetaxel)
- FDA Therapeutic Indication
- Treatment of patients with locally advanced or metastatic UC after prior platinum-containing ChT
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- IMvigor211
- NCT Number
- NCT02302807
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- EMA approved July 2017
- Comment
- Subsequent OS results for the ITT population are of exploratory nature and cannot be used for scoring.
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 8 months (2 year OS: 13%)
- OS Gain
- 0.6 months (2 year OS gain: 10%)
- OS HR
- 0.82 (0.71-0.94)
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
NEB
- Non-curative score
-
NEB
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 421
- Scorecard version
- 1
- Issue date
- 21.12.2023
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.