4
Indication details
- Control Arm
- ChT ((5-fluorouracil–based therapy with or without bevacizumab or cetuximab)
- FDA Therapeutic Indication
- First-line treatment of adults with MSI-H or dMMR mCRC
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- dMMR or MSI-H
- Trial Name
- KEYNOTE-177
- NCT Number
- NCT02563002
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2020
- EMA Approval
- EMA (CHMP) approval December 2020 EC decision January 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.2 months
- PFS Gain
- 8.3 months
- PFS HR
- 0.59 (0.45-0.79)
- OS HR
- 0.74 (0.53-1.03) Not significant (mature)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
- Toxicity Comment
-
Less serious adverse events observed
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- 1+
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 301
- Scorecard version
- 1
- Issue date
- 25.10.2021
- Last update
- 08.02.204
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.