A
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Adjuvant treatment of adults with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Adjuvant
- Trial Name
- KEYNOTE-564
- NCT Number
- NCT03142334
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2021
- EMA Approval
- EMA (CHMP) December 2021 EC Decision February 2022
Primary Outcome(s)
- Primary Outcome(s)
- DFS
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 48-month OS: 86.0%
- OS Gain
- 48-month OS gain: 5.2%
- OS HR
- 0.62 (0.44-0.87)
- DFS Control
- 48-month DFS: 56.6%
- DFS Gain
- 48-month DFS: 8.3%
- DFS HR
- 0.72 (0.59-0.87)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
21% of pembrolizumab patients discontinued treatment early because of adverse effects, 10% serious
Score (after adjustments)
- Curative score
-
A
- Comment
-
EMA (CHMP) December 2021 EC decision February 2022
FDA approval November 2021
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 313
- Scorecard version
- 1
- Issue date
- 20.01.2022
- Last update
- 29.04.2024
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.