3
Indication details
- Control Arm
- Placebo (Crossover allowed)
- Therapeutic Indication
- Treatment for 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)*
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final 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
EMA (CHMP) September 2021 EC decision November 2021
FDA approval May 2020
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 228
- Scorecard version
- 1
- Issue date
- 4.11.2020
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.