A
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- FDA theraputic indication: adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC following complete resection. EMA 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-716
- NCT Number
- NCT03553836
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2021
- 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 with stage III melanoma and lymph node involvement who have undergone complete resection. The extension to this existing indication combines two trials KEYNOTE-716 and KEYNOTE-54 (reported in scorecard -173-1)
Primary Outcome(s)
- Primary Outcome(s)
- RFS
- Evaluated Outcome
- RFS
- Form(s)
- Form 1
Outcome Data
- RFS Control
- 63.4% at 36 months
- RFS Gain
- 12.8% at 36 months
- RFS HR
- 0.62 (0.49-0.79)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
Treatment discontinuation due to treatment-related AEs: 15.9% versus 2.5%
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 339
- Scorecard version
- 1
- Issue date
- 30.05.2022
- Last update
- 28.06.2024
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.