3
Indication details
- Control Arm
- Single arm cohort study (Phase II)
- Therapeutic Indication
- Treatment of MSI-H or dMMR tumours in adults with unresectable or metastatic biliary cancer, who have disease progression on or following at least one prior therapy.
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Biliary tract cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- dMMR or MSI-H
- Trial Name
- KEYNOTE-158
- NCT Number
- NCT02628067
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval is tumour agnostic
- EMA Approval
- EMA (CHMP) March 2022 EC decision May 2022
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 4.2 months
- ORR
- 40.90%
- DoR
- 30.6 months
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
EMA (CHMP) March 2022 EC decision May 2022
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 335
- Scorecard version
- 1
- Issue date
- 28.04.2022
- Last update
- 18.01.2024
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.