2
Indication details
- Combined Agent(s)
- Pembrolizumab
- Control Arm
- Single arm
- FDA Therapeutic Indication
- For patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- EV-103/KEYNOTE-869
- NCT Number
- NCT03288545
- Trial Phase
- Phase I/II
Approval details
- FDA Approval
- FDA accelerated approval April 2023
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Gain
- Not reached
- ORR
- 64.50%
- DoR
- Not reached
Adjustments
- Annotation
- Pending publication for EV-302 (confirmatory trial)
- QoL Comment
-
QoL was not a prespecified endpoint
- Toxicity Comment
-
>30% grade 3-4 toxicities impacting well being
Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- -1
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 418
- 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.