4
Indication details
- Combined Agent(s)
- ChT with our without bevacizumab
- Control Arm
- Placebo + ChT with our without bevacizumab
- FDA Therapeutic Indication
- Persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥1
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Cervical Cancer
- Tumour Stage
- Persistent, recurrent or metastatic
- Tumour Sub-Group
- PD-L1 (CPS ≥1)
- Trial Name
- KEYNOTE-826
- NCT Number
- NCT03635567
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA regular approval October 2021
- EMA Approval
- EMA (CHMP) March 2022 EC decision May 2022
Primary Outcome(s)
- Primary Outcome(s)
- OS, PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 8.2 months
- PFS Gain
- 2.2 months
- PFS HR
- 0.62 (0.50-0.77)
- OS Control
- 16.5 months
- OS Gain
- 9.3 months (Calculated estimate of gain based on the PE HR 0.64)
- OS HR
- 0.64 (0.50-0.81)
Adjustments
- QoL Comment
-
QoL evaluated as an exploratory endpoint (as distinct from primary or secondary) is not eligible for ESMO-MCBS grading
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 306
- Scorecard version
- 1
- Issue date
- 10.12.2021
- Last update
- 28.03.2022
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.