4
Indication details
- Combined Agent(s)
- Platinum and fluoropyrimidine-based chemotherapy
- Control Arm
- Placebo + cisplatin and 5-FU
- Therapeutic Indication
- Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal Cancer
- Tumour Stage
- Locally advanced unresectable or metastatic
- Tumour Sub-Group
- PD-L1 CPS ≥10
- Trial Name
- KEYNOTE-590
- NCT Number
- NCT03189719
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) October 2023 pending EC decision - EMA (CHMP) May 2021 EC decision July 2021
- Comment
- EMA (CHMP) October 2023 update to therapeutic indication
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.5 months
- PFS Gain
- 2.0 months
- PFS HR
- 0.51 (0.41-0.65)
- OS Control
- 9.4 months
- OS Gain
- 4.1 months
- OS HR
- 0.62 (0.49-0.78)
Final Score (after adjustments)
- Preliminary non-curative score
-
4
- Final non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 309
- Scorecard version
- 1
- Issue date
- 10.12.2021
- Last update
- 13.11.2023
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.