A
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Adjuvant therapy for adult patients with oesophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal or gastroesophageal junction carcinoma
- Tumour Stage
- Adjuvant
- Trial Name
- CheckMate 577
- NCT Number
- NCT02743494
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2021
- EMA Approval
- EMA (CHMP) June 2021 EC decision August 2021
Primary Outcome(s)
- Primary Outcome(s)
- DFS
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 11.0 months
- DFS Gain
- 11.4 months
- DFS HR
- 0.69 (96.4%CI 0.56-0.86)
Score (after adjustments)
- Curative score
-
A
- Comment
-
EMA (CHMP) June 2021
EC decision August 2021
FDA approval May 2021
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 279
- Scorecard version
- 1
- Issue date
- 25.06.2021
- Last update
- 05.07.2021
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.