A
Indication details
- Combined Agent(s)
- Chemoradiotherapy (Cisplatin)
- Control Arm
- Placebo + Chemoradiotherapy (Cisplatin)
- Therapeutic Indication
- FDA: Pembrolizumab with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA cervical cancer. EMA: Pembrolizumab, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Cervical Cancer
- Tumour Stage
- High-risk locally advanced
- Trial Name
- ENGOT-cx11/GOG-3047/KEYNOTE-A18
- NCT Number
- NCT04221945
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval January 2024
- EMA Approval
- EMA (CHMP) approved September 2024. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- PFS investigator assessed (RECIST version 1.1) and hierarchically tested OS in the ITT
- Evaluated Outcome
- PFS. Treatment with curative intent
- Form(s)
- Form 1
Outcome Data
- PFS Control
- 2-years 57%. Median NR
- PFS Gain
- 2-years gain 11%. Median NR
- PFS HR
- 0.70 (0.55- 0.89) p-value met the interim threshold
- OS Control
- 2-years 81%. Median NR
- OS Gain
- 2-years gain 6%. Median NR
- OS HR
- 0.73 (0.49-1.07), (NS at this interim at 43% information fraction)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
> 2% AE related deaths and >10% differential discontinuation due to AE
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 459
- Scorecard version
- 1
- Issue date
- 23.09.2024
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.