A
Indication details
- Combined Agent(s)
- Gemcitabine + cisplatin
- Control Arm
- Durvalumab
- Therapeutic Indication
- Durvalumab with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Trial Name
- Phase III
- NCT Number
- NCT03732677
- Trial Phase
- NIAGARA
Approval details
- FDA Approval
- FDA approval March 2025
Primary Outcome(s)
- Primary Outcome(s)
- EFS and pCR (primary), OS (secondary)
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 24 months, 75.2%
- OS Gain
- 24 months, 7%
- OS HR
- 24 months, 0.75 (0.59 - 0.93) P=0.01 by stratified log-rank test
- EFS control
- 24 months, 59.8%
- EFS gain
- 24 months, 8%
- EFS HR
- 24 months, 0.68 (0.56 - 0.82) P<0.001
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
Premature discontinuation of therapy due to AEs in >10% of patients
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 498
- Scorecard version
- 1
- Issue date
- 18.04.2025
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.