4
Indication details
- Combined Agent(s)
- Best supportive care + octreotide
- Control Arm
- Octreotide
- Therapeutic Indication
- Unresectable or metastatic, progressive, well-differentiated (Grade 1 and Grade 2), somatostatin receptor positive-GEP-NETs in adults
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Neuroendocrine Tumour - Midgut
- Tumour Stage
- Unresectable or metastatic
- Trial Name
- NETTER-1
- NCT Number
- NCT01578239
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.4 months
- PFS Gain
- 31.6 months (Calculated estimate of gain based on point estimate HR 0.21)
- PFS HR
- 0.214 (0.13-0.33)
- OS Control
- 36.3 months
- OS Gain
- 11.7 months
- OS HR
- 0.84 (0.60-1.17) not significant
Adjustments
- QoL Comment
-
Improvement in QoL; favourable safety profile
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Final non-curative score
-
4
- Comment
-
EMA (CHMP) July 2017 EC approval September 2017
FDA approval January 2018
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 152
- Scorecard version
- 1
- Issue date
- 12.03.2020
- Last update
- 08.03.2023
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.