2
Indication details
- Combined Agent(s)
- Bevacizumab
- Control Arm
- Placebo + bevacizumab
- Therapeutic Indication
- Maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- High-grade epithelial ovarian, fallopian tube or primary peritoneal cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HRD+, BRCA-WT
- Trial Name
- PAOLA-1
- NCT Number
- NCT02477644
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2020
- EMA Approval
- EMA (CHMP)September 2020. EC decision November 2020
- Comment
- Exploratory subgroup analysis deemed important in this clinical setting.
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 16.6 months
- PFS Gain
- 13.4 months
- PFS HR
- 0.47 (0.32-0.70)
- OS Control
- OS: 52.0 months 5-year OS rate: 44.2%
- OS Gain
- Estimated OS gain: 21.2 months 5-year OS rate gain: 10.5%
- OS HR
- 0.71 (0.45-1.13) OS NS (mature)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
>10% incremental discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
3
- Only improved PFS mature data shows no OS advantage and no improved QoL
- 1-
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 247
- Scorecard version
- 1
- Issue date
- 26.03.2021
- Last update
- 21.11.2024
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.