4
Indication details
- Control Arm
- Sunitinib
- Therapeutic Indication
- First-line treatment of adult patients with intermediate/poor-risk advanced RCC
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- CheckMate 214
- NCT Number
- NCT02231749
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval April 2018
- EMA Approval
- EMA (CHMP) November 2018 EC decision January 2019
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 26.6 months
- OS Gain
- 21.5 months
- OS HR
- 0.68 (0.58-0.81)
Adjustments
- QoL Comment
-
QoL benefit reported in exploratory evaluation not eligible for QoL adjustment.
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
EMA (CHMP) November 2018 EC decision January 2019
FDA approval April 2018
Benefit may be exaggerated by low prevalence of subsequent immunotherapy in patients progressing in the control arm, indicating substandard post-progression therapy.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 117
- Scorecard version
- 1
- Issue date
- 17.02.2020
- Last update
- 15.05.2023
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.