5
Indication details
- Control Arm
- Vemurafenib
- FDA Therapeutic Indication
- Dabrafenib in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- BRAF V600
- Trial Name
- COMBI-v
- NCT Number
- NCT01584648│NCT01597908
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) July 2018 EC decision September 2018
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 7.3 months
- PFS Gain
- 4.1 months
- PFS HR
- 0.56 (0.46-0.69)
- OS Control
- 18.0 months* 3-years survival 31%
- OS Gain
- 8.0 months * 3-years survival 13%
- OS HR
- 0.69 (0.53-0.89) Interim OS (p=0.005<0.02)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
- Toxicity Comment
-
17% reduction skin cancer
Score (after adjustments)
- Preliminary non-curative score
-
4
- Toxicity adjustment
- 1+
- Non-curative score
-
5
- Comment
-
* Estimated from Kaplan-Meier plot.
EMA (CHMP) July 2015 EC decision September 2015
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 87
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 16.01.2023
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.