A
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- PD-L1 expression ≥1%
- Trial Name
- CheckMate 274
- NCT Number
- NCT02632409
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA approval February 2022 EC decision April 2022
Primary Outcome(s)
- Primary Outcome(s)
- DFS in ITT and PDL1>1% (coprimary)
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- OS immature
- DFS Control
- 6 months DFS 55.7%
- DFS Gain
- 6 months DFS 18.8%
- DFS HR
- 0.55 (98.72% CI 0.35-0.85)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
- Toxicity Comment
-
Discontinuation due to adverse effects 12.8% vs 2.0%
Score (after adjustments)
- Curative score
-
A
- Comment
-
EMA (CHMP) February 2022 EC decision April 2022 in the PD-L1 expression ≥1% population
FDA approval August 2021 in the ITT population
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 324
- Scorecard version
- 1
- Issue date
- 31.03.2022
- Last update
- 11.11.2022
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.