2
Indication details
- Control Arm
- Placebo
- 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