3
Indication details
- Control Arm
- Placebo (Crossover allowed)
- Therapeutic Indication
- EMA: Ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. FDA: Ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- GIST
- Tumour Stage
- Advanced
- Trial Name
- INVICTUS
- NCT Number
- NCT03353753
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2020
- EMA Approval
- EMA (CHMP) September 2021. EC decision November 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 1.0 months
- PFS Gain
- 5.3 months
- PFS HR
- 0.15 (0.09 - 0.25)
- OS Control
- 6.6 months
- OS Gain
- 8.5 months
- OS HR
- 0.36 (0.21-0.62)*
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
*Owing to the hierarchal testing procedure of the endpoints, overall survival could not be formally tested for statistical significance because the objective response was not significant
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 228
- Scorecard version
- 1
- Issue date
- 4.11.2020
- Last update
- 20.03.2025
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.