3
Indication details
- Control Arm
- Chemotherapy
- Therapeutic Indication
- Locally advanced or metastatic oesophageal or OGJ carcinoma that is not amenable to surgical resection or definitive CRT after ≥1 prior lines of systemic therapy for patients with tumours of squamous cell histology that express PD-L1 (CPS ≥10)
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal or gastroesophageal junction carcinoma
- Tumour Stage
- Advanced or metastatic
- Trial Name
- KEYNOTE-181
- NCT Number
- NCT02564263
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval July 2019
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 6.7 months
- OS Gain
- 2.6 months
- OS HR
- 0.69 (0.52-0.93)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 479
- Scorecard version
- 1
- Issue date
- 06.12.2024
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.