A
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB, IIC or III melanoma and who have undergone complete resection
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Adjuvant
- Trial Name
- KEYNOTE-054
- NCT Number
- NCT02362594
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) May 2022 extension to an existing indication EC decision July 2022 previous approval EMA (CHMP) October 2018 EC decision December 2018
- Comment
- EMA previous therapeutic indication: adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection. The extension to this existing indication combines two trials KEYNOTE-054 and KEYNOTE-716 (reported in scorecard 339-1)
Primary Outcome(s)
- Primary Outcome(s)
- RFS
- Evaluated Outcome
- RFS
- Form(s)
- Form 1
Outcome Data
- RFS Control
- 1-year 61%
- RFS Gain
- 1-year 14.4%
- RFS HR
- 056 (0.47-0.68)
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
Higher incidence of acute and persisting adverse effects
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 173
- Scorecard version
- 1
- Issue date
- 09.06.2020
- Last update
- 03.11.2023
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.