1
Indication details
- Combined Agent(s)
- Cabozantinib
- Control Arm
- Sunitinib
- Therapeutic Indication
- First-line treatment of adult patients with advanced RCC
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- CheckMate-9ER
- NCT Number
- NCT03141177
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2021
- EMA Approval
- EMA (CHMP) February 2021 EC Decision April 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 8.3 months
- PFS Gain
- 8.3 months
- PFS HR
- 0.56 (0.46-0.68)
- OS Control
- 34.3 months
- OS Gain
- 3.4 months
- OS HR
- 0.70 (0.55-0.90)
Adjustments
- QoL Comment
-
QoL evaluated as an exploratory endpoint (as distinct from primary or secondary endpoint) is not eligible for ESMO-MCBS grading
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- EDMO-MCBS v1.1
- Scorecard ID
- 272
- Scorecard version
- 1
- Issue date
- 21.05.2021
- Last update
- 06.06.2023
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.