2
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Maintenance treatment of adult patients with gBRCAm who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line ChT regimen
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Pancreatic cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- gBRCAm
- Trial Name
- POLO
- NCT Number
- NCT02184195
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2019
- EMA Approval
- EMA (CHMP) May 2020 EC decision July 2020
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.8 months
- PFS Gain
- 3.6 months
- PFS HR
- 0.53 (0.35-0.82)
- OS Control
- 19.2 months
- OS Gain
- (0.2 month)
- OS HR
- 0.83 (0.56-1.22) Not significant
Adjustments
- QoL Comment
-
No QoL benefit
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
- 208
- Scorecard version
- 1
- Issue date
- 23.07.2020
- Last update
- 19.07.2023
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.