3
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Cabozantinib for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Neuroendocrine tumour - extra-pancreatic
- Tumour Stage
- Advanced
- Trial Name
- CABINET
- NCT Number
- NCT03375320
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2025
Primary Outcome(s)
- Primary Outcome(s)
- PFS (primary), ORR (secondary), OS (secondary)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.9 months
- PFS Gain
- 4.5 months
- PFS HR
- 0.38 (0.25 - 0.59) P<0.001)
- OS Control
- 19.7 months
- OS Gain
- 2.2 months
- OS HR
- 0.86 (0.56 - 1.31), NS, immature
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
>20% increase Gr3+ AEs impacting on daily well-being and premature discontinuation of therapy due to AEs in >10% of patients
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 496
- Scorecard version
- 1
- Issue date
- 18.04.2025
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.