3
Indication details
- Combined Agent(s)
- ADT (androgen deprivation therapy)
- Control Arm
- Placebo + ADT
- Therapeutic Indication
- For the 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
- ARCHES
- NCT Number
- NCT02677896
- 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)
- rPFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 38.9 months
- PFS Gain
- 10.9 months
- PFS HR
- 0.63 (0.52-0.76)
- OS Control
- Median OS: NR (median follow-up 44.6 months) 4-year OS: 57% *
- OS Gain
- 4-year OS gain: 14%
- OS HR
- 0.66 (0.53-0.81)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- 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
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 269
- Scorecard version
- 1
- Issue date
- 27.04.2021
- 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.