3
Indication details
- Combined Agent(s)
- Enzalutamide
- Control Arm
- Placebo + enzalutamide
- Therapeutic Indication
- Talazoparib with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Prostate cancer
- Tumour Stage
- Metastatic castration-resistant
- Tumour Sub-Group
- HRR gene-mutated
- Trial Name
- TALAPRO-2
- NCT Number
- NCT03395197
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2023
- Comment
- The presented score is for the HRR-deficient population.
Primary Outcome(s)
- Primary Outcome(s)
- rPFS
- Evaluated Outcome
- rPFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 13.8 months
- PFS Gain
- 16.9 months (estimated from Ctrl and HR)
- PFS HR
- 0.45 (0.33 - 0.61)
- OS HR
- OS NS (Immature)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 441
- Scorecard version
- 1
- Issue date
- 05.06.2024
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.