3
Indication details
- Combined Agent(s)
- Cisplatin and 5-FU
- Control Arm
- Placebo + cisplatin and 5-FU
- FDA Therapeutic Indication
- First-line treatment locally advanced or metastatic oesophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive CRT in combination with platinum- and fluoropyrimidine-based ChT
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal or gastroesophageal junction carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- HER2- GEJ (all randomized)
- Trial Name
- KEYNOTE-590
- NCT Number
- NCT03189719
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2021 FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.8 months
- PFS Gain
- 0.5 months
- PFS HR
- 0.65 (0.55-0.76)
- OS Control
- 9.8 months
- OS Gain
- 2.6 months - 12% improvement at 2-years but <10% of patients still on follow up by that time
- OS HR
- 0.73 (0.62-0.86)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
FDA approval March 2021
FDA approval is irrespective of tumour PD-L1 status and so data shown are for all randomised patients.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 308
- Scorecard version
- 1
- Issue date
- 10.12.2021
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.