4
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) 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
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- High-grade epithelial ovarian, fallopian tube or primary peritoneal cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- BRCA-mut
- Trial Name
- SOLO-1
- NCT Number
- NCT01844986
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved December 2018
- EMA Approval
- EMA (CHMP) February 2019 EC approved April 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 13.8 months
- PFS Gain
- 42.2 months
- PFS HR
- 0.33 (0.25-0.43) >10% gain in PFS at 24 months with plateau
- OS HR
- OS Not significant (immature) P = 0.0004 (P<0.0001 required to declare statistical significance)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- >10% gain in PFS at 24 months with plateau
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 144
- 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.