2
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Maintenance therapy in 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 ChT
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Ovarian, fallopian tubes and peritoneum cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- BRCA-mut
- Trial Name
- SOLO-2
- NCT Number
- NCT01874353
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2017
- EMA Approval
- EMA (CHMP) April 2019. EC decision June 2019
- Comment
- EMA and FDA approval based on both SOLO-2 and Study-19
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.5 months
- PFS Gain
- 13.6 months
- PFS HR
- 0.30 (0.22-0.41)
- OS Control
- 38.8 months
- OS Gain
- 12.9 months
- OS HR
- 0.74 (0.54-1.00) OS NS (mature)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
4% vs 0% treatment-emergent AEs leading to death
>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
- 145
- Scorecard version
- 1
- Issue date
- 10.01.2020
- 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.