A
5
Indication details
- Combined Agent(s)
- Encorafenib
- Control Arm
- Vemurafenib
- Therapeutic Indication
- In combination with encorafenib 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
- COLUMBUS
- NCT Number
- NCT01909453
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) July 2018 EC decision September 2018
- Comment
- For patients in whom the decision to treat with targeted therapy has been made, patients who cannot receive a MEKi (e.g. due to cardiovascular comorbidities, a recent BM bleeding event, history of retinal detachment or other ophthalmological contraindication), can be offered encorafenib as monotherapy [II, B; not FDA or EMA approved].This is based on a post hoc analysis of OS showing near equivalence between encorafanib monotherapy and encorafenib-binimetinib HR 0.93( 0.73-1.18)
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- PFS Control
- 7.3 months
- PFS Gain
- 7.6 months
- PFS HR
- 0.51 (0.40-0.67)
- OS Control
- 16.9 months, 7-year 18.2%
- OS Gain
- 16.7 months, 7-year 9.2%
- OS HR
- 0.67 (0.53-0.84)
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
4
- Long-term plateau in the survival curve
- There is a long term plateau in the survival curve, and OS advantage continues to be observed at 5 years has also been scored according to form 1 (treatments with curative potential)
- QoL adjustment
- 1+
- Non-curative score
-
5
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 168
- Scorecard version
- 1
- Issue date
- 21.04.2020
- Last update
- 31.07.2024
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.