A
4
Indication details
- Control Arm
- Ipilimumab
- Therapeutic Indication
- Treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced unresectable or metastatic
- Trial Name
- KEYNOTE-006
- NCT Number
- NCT01866319
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2015
- EMA Approval
- EMA (CHMP) May 2022 extension to an existing indication EC decision July 2022 EMA (CHMP) May 2015 EC decision July 2015
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- OS Control
- 15.9 months 5-year 31.0%
- OS Gain
- 16.8 months 5-year 7.7%
- OS HR
- 0.73 (0.61-0.88)
Adjustments
- QoL Comment
-
Exploratory endpoint not eligible for scoring
- Toxicity Comment
-
Similar toxicity (based on grade ≥3 AEs)
Final 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)
- Final non-curative score
-
4
- Final curative score
-
A
- Comment
-
Reported HR is for the 3-week schedule of pembrolizumab
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 327
- Scorecard version
- 1
- Issue date
- 19.04.2022
- Last update
- 05.06.2023
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.