3
Indication details
- Combined Agent(s)
- Prednisolone or prednisone
- Control Arm
- Placebo plus abiraterone acetate + prednisone
- Therapeutic Indication
- For the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic)
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic castration-resistant
- Tumour Sub-Group
- BRCA-mutated
- Trial Name
- MAGNITUDE (Cohort 1)
- NCT Number
- NCT03748641
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2023
- EMA Approval
- EMA (CHMP) February 2023 EC decision June 2023
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 10.9 months
- PFS Gain
- 8.6 months
- PFS HR
- 0.55 (0.39-0.78)
- OS HR
- OS NS immature
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 395
- Scorecard version
- 1
- Issue date
- 22.09.2023
- Last update
- 15.11.2024
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.