2
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Phase II)
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- High-grade epithelial ovarian, fallopian tube or primary peritoneal cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- BRCA-mut
- Trial Name
- Study 19
- NCT Number
- NCT00753545
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval August 2017
- EMA Approval
- EMA (CHMP) April 2019 EC decision June 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.3 months
- PFS Gain
- 6.9 months
- PFS HR
- 0.18 (0.10-0.31)
- OS Control
- 30.2 months
- OS Gain
- 4.7 months
- OS HR
- 0.62 (0.42-0.93), nominal P = 0.0214 (did not reach threshold for significance) (mature)
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
- 47
- Scorecard version
- 1
- Issue date
- 11.12.2018
- 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.