4
Indication details
- Combined Agent(s)
- ADT (androgen deprivation therapy)
- Control Arm
- ADT
- Therapeutic Indication
- Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic
- Trial Name
- ENZAMET
- NCT Number
- NCT02446405
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2019
- EMA Approval
- EMA (CHMP) March 2021 EC decision May 2021
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 24 months (Estimated from Kaplan Meier Plot)
- PFS Gain
- 36 months (Calculated estimate of gain based on PE HR 0.40)
- PFS HR
- 0.40 (0.33-0.49)
- OS Control
- 72% at 3-years*
- OS Gain
- 8% at 3-years
- OS HR
- 0.67 (0.52-0.86) interim OS (p=0.002 <0.003 threshold for interim analysis)
Adjustments
- QoL Comment
-
Improved QoL
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- OS advantage continues to be observed
- 1+
- Final non-curative score
-
4
- Comment
-
*OS of the control arm may be overestimated by inadequate post-progression treatment of control arm patients with abiraterone or enzalutamide when castrate resistant
**Form 2a cannot be applied since median OS not reached in the control arm, consequently, score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected at interim analysis
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 178
- Scorecard version
- 1
- Issue date
- 30.06.2020
- Last update
- 08.08.2023
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.