3
Indication details
- Combined Agent(s)
- Leuprolide
- Control Arm
- Placebo + Leuprolide
- Therapeutic Indication
- As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy. Combination group
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Non-metastatic castration-sensitive
- Tumour Sub-Group
- PSA doubling time ≤ 9 months
- Trial Name
- EMBARK
- NCT Number
- NCT02319837
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2023
- EMA Approval
- EMA (CHMP) approved March 2024. EC decision June 2024
- Comment
- Combination group
Primary Outcome(s)
- Primary Outcome(s)
- Imagining-based MFS-PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- Estimated median >70 months; 5 years 71.4%
- PFS Gain
- Estimated median gain >90 months, 5-year gain 15.9%
- PFS HR
- 0.42 (0.30 - 0.61)
- OS Control
- OS NS immature
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
20.7% vs 10.2% discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 420
- Scorecard version
- 1
- Issue date
- 16.01.2024
- Last update
- 22.10.2024
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.