4
Indication details
- Combined Agent(s)
- Pembrolizumab
- Control Arm
- Platinum-based ChT
- FDA Therapeutic Indication
- FDA: Enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer. EMA: Pembrolizumab, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- EV-302/KN-A39
- NCT Number
- NCT04223856
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2023
- EMA Approval
- EMA CHMP July 2024 EC decision August 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 6.3 months
- PFS Gain
- 6.2 months
- PFS HR
- 0.45 (0.38-0.54)
- OS Control
- 16.1 months
- OS Gain
- 15.4 months
- OS HR
- 0.47 (0.38-0.58) interim at 73% of info
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
- 433
- Scorecard version
- 1
- Issue date
- 30.04.2024
- Last update
- 29.07.2024
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.