4
Indication details
- Combined Agent(s)
- Lenvatinib
- Control Arm
- Treatment of physician's choice (doxorubicin or paclitaxel)
- Therapeutic Indication
- Patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or RT
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Endometrial Cancer
- Tumour Stage
- Advanced
- Trial Name
- KEYNOTE-775
- NCT Number
- NCT03517449
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA regular approval July 2020
- EMA Approval
- EMA (CHMP) October 2021 EC decision December 2021
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 3.8 months
- PFS Gain
- 2.8 months
- PFS HR
- 0.60 (0.50-0.72)
- OS Control
- 12.0 months
- OS Gain
- 5.4 months
- OS HR
- 0.68 (0.56-0.84)
Adjustments
- QoL Comment
-
No difference in QoL between treatment groups
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
FDA regular approval July 2020
FDA approval is restricted to patients whose tumours are not MSI-H or dMMR and so data shown are for the pMMR study population
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 337
- Scorecard version
- 1
- Issue date
- 28.04.2022
- Last update
- 20.03.2023
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.