4
Indication details
- Control Arm
- Investigator-chosen ChT (standard docetaxel, paclitaxel or vinflunine)
- FDA Therapeutic Indication
- Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- EV-301
- NCT Number
- NCT03474107
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA regular approval July 2021
- EMA Approval
- EMA (CHMP) December 2021 and February 2022 EC decision May 2022
- Comment
- FDA approval also for patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Previously granted accelerated approval in December 2019 by the FDA in a phase II single-arm study, this is the phase III confirmatory trial
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 8.94 months
- OS Gain
- 3.97 months
- OS HR
- 0.70 (0.58-0.85)
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
- 286
- Scorecard version
- 1
- Issue date
- 31.08.2021
- Last update
- 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.