3
Indication details
- Combined Agent(s)
- Carboplatin and paclitaxel
- Control Arm
- Carboplatin, paclitaxel, and placebo (arm A)
- Therapeutic Indication
- FDA: Durvalumab is indicated with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). EMA: Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy followed by maintenance treatment with durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Endometrial Cancer
- Tumour Stage
- Primary advanced or recurrent
- Trial Name
- DUO-E
- NCT Number
- NCT04269200
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2024
- EMA Approval
- EMA (CHMP) June 2024. EC decision August 2024
- Comment
- Monotherapy treatment in ITT (durvalumab only, arm B). Approval based on pre-specified, exploratory subgroup analysis in dMMR: PFS HR 0.42 (0.22-0.80) and 7 months for control PFS. PFS NR for the Durvalumab arm: estimated gain 9.7 months.
Primary Outcome(s)
- Primary Outcome(s)
- PFS (investigator assessment)
- Evaluated Outcome
- PFS (ITT)
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 9.6 months
- PFS Gain
- 0.6 months, >10% gain at 24 months
- PFS HR
- 0.71 (0.57-0.89)
- OS Control
- 25.9 months (interim analysis)
- OS Gain
- NR (estimated 7.7 months)
- OS HR
- 0.77 (0.56-1.07) NS (p=0.12)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
2
- Long-term plateau in the PFS curve
- 5% available at 24m
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 452
- 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.