4
Indication details
- Control Arm
- Leuprolide
- FDA Therapeutic Indication
- Treatment of adult patients with advanced HSPC
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Advanced
- Trial Name
- HERO
- NCT Number
- NCT03085095
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2020
- EMA Approval
- EMA (CHMP) February 2022. EC decision May 2022
Primary Outcome(s)
- Primary Outcome(s)
- PFS (non-inferiority). Primary: sustained castration rate at 48 weeks with relugolix. Secondary hierarchical tested: non-inferiority of relugolix to leuprolide with respect to the primary endpoint (margin: -10 percentage points), superiority
- Evaluated Outcome
- PFS (NI)
- Form(s)
- Form 2c
Outcome Data
- PFS HR
- Non-inferior and superior castration rate between group difference: 7.9 percentage points (95%CI 4.1-11.8)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
Significantly lower risk of major cardiovascular events (HR 0.46 95%CI 0.24-0.88)
- QoL or Toxicity non-inferiority or superiority in PFS/OS
- Reduced toxicity with proven superiority of relugolix with respect to castration rate
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 321
- Scorecard version
- 1
- Issue date
- 31.03.2022
- 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.