3
Indication details
- Combined Agent(s)
- Axitinib
- 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
- JAVELIN Renal 101
- NCT Number
- NCT02684006
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2019
- EMA Approval
- EMA CHMP September 2019 EC decision November 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS (ITT)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.0 months
- PFS Gain
- 5.3 months
- PFS HR
- 0.69 (0.57-0.83)
- OS HR
- OS not significant (immature)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
EMA CHMP November 2019 EC decision January 2020
FDA approval May 2019
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 147
- 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.