4
Indication details
- Combined Agent(s)
- Carboplatin and paclitaxel
- Control Arm
- Placebo + carboplatin + paclitaxel
- Therapeutic Indication
- Dostarlimab with carboplatin and paclitaxel, followed by single-agent dostarlimab, for adult patients with primary advanced or recurrent endometrial cancer (EC)
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Endometrial Cancer
- Tumour Stage
- Primary advanced or recurrent
- Trial Name
- RUBY
- NCT Number
- NCT03981796
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS both primary endpoints in ITT
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 28.2 months
- OS Gain
- 16.4 months
- OS HR
- 0.69 (0.54- 0.89). P= <0.01101 (stopping boundary)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
19.1 % vs 8.1% discontinuation due to toxicity
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 463
- Scorecard version
- 1
- Issue date
- 09.10.2024
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.