3
Indication details
- Control Arm
- Paclitaxel, pegylated liposomal doxorubicin, or topotecan. (Investigator’s choice of chemotherapy)
- Therapeutic Indication
- Mirvetuximab soravtansine for adult patients with FRα positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1-3 prior systemic treatment regimens
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Epithelial ovarian, fallopian tube or primary peritoneal cancer
- Tumour Sub-Group
- FRalpha positive
- Trial Name
- MIRASOL, Study 0416
- NCT Number
- NCT04209855
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2024
- EMA Approval
- EMA (CHMP) approved September 2024. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- Investigator-assessed PFS, then hierarchically tested ORR, OS and PROs
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 3.98 months
- PFS Gain
- 1.64 months
- PFS HR
- Not reported
- OS Control
- 12.75 months
- OS Gain
- 3.7 months
- OS HR
- 0.67 (0.50-0.89)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 435
- Scorecard version
- 1
- Issue date
- 06.05.2024
- Last update
- 21.11.2024
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.