4
Indication details
- Combined Agent(s)
- Axitinib
- Control Arm
- Sunitinib
- FDA Therapeutic Indication
- First-line treatment of advanced RCC in adults
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- KEYNOTE-426
- NCT Number
- NCT02853331
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2014
- EMA Approval
- EMA (CHMP) July 2019 EC decision September 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 11.1 months
- PFS Gain
- 4.3 months
- PFS HR
- 0.71 (0.60-0.84)
- OS Control
- 35.7 months
- OS Gain
- 16.8 (Calculated estimate of gain based on PE HR 0.68)
- OS HR
- 0.68 (0.55-0.85)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
Benefit may be exaggerated by low prevalence of subsequent immunotherapy in patients progressing in the control arm, indicating substandard post-progression therapy.
EMA (CHMP) July 2019 EC decision September 2019
FDA approval April 2019
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 146
- 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.