4
Indication details
- Combined Agent(s)
- Carboplatin and paclitaxel
- Control Arm
- Carboplatin, paclitaxel, and placebo
- FDA Therapeutic Indication
- Pembrolizumab with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. (Cohort data with dMMR)
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Endometrial Cancer
- Tumour Stage
- Recurrent or advanced
- Tumour Sub-Group
- dMMR
- Trial Name
- KEYNOTE-868/NRG-GY018
- NCT Number
- NCT03914612
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2024
- Comment
- Approval for cohort data with dMMR
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 12 months, 38%
- PFS Gain
- 12 months, 36%
- PFS HR
- 0.30 (0.19- 0.48)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- 9 patients (8%) available at 24m
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 453
- Scorecard version
- 1
- Issue date
- 24.07.2024
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.