4
Indication details
- Combined Agent(s)
- Cisplatin or carboplatin/5-FU
- Control Arm
- Cisplatin or carboplatin/5-FU/cetuximab
- FDA Therapeutic Indication
- First-line treatment of patients with metastatic or unresectable, recurrent SCCHN
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Squamous cell
- Tumour Stage
- Recurrent or metastatic
- Trial Name
- KEYNOTE-048
- NCT Number
- NCT02358031
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2019
- EMA Approval
- EMA approved
- Comment
- EMA approved for PD-L1 CPS ≥1
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 10.7 months 2-year OS: 18.4%
- OS Gain
- 2.3 months 2-year OS gain: 11.0%
- OS HR
- 0.71 (0.59-0.85)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
Three-arm trial comparing chemotherapy plus cetuximab versus chemotherapy plus pembrolizumab versus pembrolizumab monotherapy.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 386
- Scorecard version
- 1
- Issue date
- 07.08.2023
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.