5
Indication details
- Combined Agent(s)
- Best standard of care (restricted)
- Control Arm
- Best standard of care (restricted)
- FDA Therapeutic Indication
- In combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- PSMA-positive mCRPC
- Trial Name
- VISION
- NCT Number
- NCT03511664
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2022
- EMA Approval
- EMA (CHMP) October 2022 EC decision December 2022
Primary Outcome(s)
- Primary Outcome(s)
- Imagining-based PFS and OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 3.4 months
- PFS Gain
- 5.3 months
- PFS HR
- 0.40 (99.2% CI, 0.29-0.57)
- OS Control
- 11.3 months*
- OS Gain
- 4.0 months
- OS HR
- 0.62 (0.52-0.74)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
Deteriorated toxicity (based on grade ≥3 AEs) 52.7% vs 38%
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- 1+
- Non-curative score
-
5
- Comment
-
*Substandard control arm: precluded cabazitaxel
Scorecard details
- ESMO-MCBS version
- ESO-MCBS v1.1
- Scorecard ID
- 329
- Scorecard version
- 1
- Issue date
- 21.04.2022
- 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.