1
Indication details
- Control Arm
- Sorafenib
- Therapeutic Indication
- First-line treatment and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- TIVO-1
- NCT Number
- NCT01030783
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) June 2017 EC decision November 2017
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 9.1 months
- PFS Gain
- 2.8 months
- PFS HR
- 0.80 (0.64-0.99)
- OS Control
- 28.8 months
- OS Gain
- 0.5 months
- OS HR
- 1.245 (0.954-1.624) Not significant (mature)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
2
- Only improved PFS mature data shows no OS advantage and no improved QoL
- 1-
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 118
- Scorecard version
- 1
- Issue date
- 21.02.2019
- Last update
- 03.08.2023
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.