3
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Vorasidenib, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection
- Tumour Type
-
Brain Tumours
- Tumour Sub-type
- Glioma (low grade). (Grade 2 astrocytoma or oligodendroglioma)
- Tumour Stage
- Residual or recurrent
- Tumour Sub-Group
- IDH1 or IDH2 mutation
- Trial Name
- INDIGO
- NCT Number
- NCT04164901
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS (RANO-LGG criteria). OS as secondary endpoint
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 11.1 months
- PFS Gain
- 16.6 months
- PFS HR
- 0.39 (0.27-0.56) P<0.001
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 461
- Scorecard version
- 1
- Issue date
- 09.10.2024
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.