5
Indication details
- Control Arm
- Investigator's choice of ChT
- FDA Therapeutic Indication
- Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Cervical Cancer
- Tumour Stage
- Recurrent or metastatic
- Trial Name
- EMPOWER-Cervical 1
- NCT Number
- NCT03257267
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- EMA (CHMP) October 2022 EC decision December 2022
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 8.5 months
- OS Gain
- 3.5 months
- OS HR
- 0.69 (0.56-0.84)
Adjustments
- QoL Comment
-
QoL was a secondary endpoint no significant or clinically meaningful improvement
Score (after adjustments)
- Preliminary non-curative score
-
4
- Toxicity adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- Scorecard ID
- 361
- Scorecard version
- 1
- Issue date
- 23.11.2022
- Last update
- 03.07.2023
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.