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2

Indication details

Control Arm
Single arm
Tumour Type
Gynaecological Malignancies
Tumour Sub-type
Epithelial ovarian, fallopian tube or primary peritoneal cancer
Tumour Stage
Advanced
Tumour Sub-Group
FRα positive
Trial Name
SORAYA
NCT Number
NCT04296890
Trial Phase
Phase II

Approval details

FDA Approval
FDA approval March 2024
EMA Approval
EMA approved Sept 2024

Primary Outcome(s)

Primary Outcome(s)
ORR DOR
Evaluated Outcome
ORR DOR
Form(s)
Form 3

Outcome Data

PFS Control
4.3 months
ORR
32.4%
DoR
6.9 months

Adjustments

QoL Comment
Not qualified for an ESMO-MCBS credit

Score (after adjustments)

Preliminary non-curative score

2

Non-curative score

2

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
376
Scorecard version
1
Issue date
21.04.2023
Last update
21.11.2024
Mirvetuximab soravtansine SORAYA

PRELIMINARY SCORE

ORR

ADJUSTMENTS

Not qualified for an ESMO-MCBS credit
Mirvetuximab soravtansine SORAYA

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
2
Overall Response Rate / Duration of Response
Gynaecological Malignancies
Mirvetuximab soravtansine
Single arm

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