4
Indication details
- Control Arm
- Investigator’s choice of ChT (paclitaxel, docetaxel or vinflunine)
- Therapeutic Indication
- Locally advanced or metastatic UC in adults who have received prior platinum-containing ChT
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- KEYNOTE-045
- NCT Number
- NCT02256436
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved May 2017
- EMA Approval
- EMA (CHMP) July 2017 EC decision September 2017
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 7.2 months, 2-year OS: 14.3%
- OS Gain
- 2.9 months, 2-year OS gain: 12.6%
- OS HR
- 0.71 (0.59-0.86)
Adjustments
- QoL Comment
-
Qol was an exploratory endpoint
- Toxicity Comment
-
Fewer grade 3/4 treatment-related AEs versus control (p<0.001) but not affecting daily well-being.
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 278
- Scorecard version
- 1
- Issue date
- 14.06.2021
- 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.