3
Indication details
- Combined Agent(s)
- Interferon
- Control Arm
- Interferon + placebo
- FDA Therapeutic Indication
- In combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Metastatic
- Trial Name
- AVOREN
- NCT Number
- NCT00738530 (BO17705E in CenterWatch)
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval
- EMA Approval
- EMA (CHMP) September 2012 EC decision November 2012
Primary Outcome(s)
- Primary Outcome(s)
- OS and PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.4 months
- PFS Gain
- 4.8 months
- PFS HR
- 0.63 (0.52-0.75)
- OS HR
- Not significant (mature)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
Although mature OS is not significant, no downgrade as crossover was permitted and QoL cannot be assessed
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 110
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 07.08.2023
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.