4
Indication details
- Combined Agent(s)
- Cisplatin or carboplatin/5-FU
- Control Arm
- Cisplatin or carboplatin/5-FU/cetuximab
- FDA Therapeutic Indication
- In combination with platinum and 5‑fluorouracil (5‑FU) chemotherapy is indicated for the first‑line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Squamous cell
- Tumour Stage
- Recurrent or metastatic
- Tumour Sub-Group
- CPS PD-L1 expression ≥20
- Trial Name
- KEYNOTE-048
- NCT Number
- NCT02358031
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved
- EMA Approval
- EMA (CHMP) October 2019 EC decision December 2019
- Comment
- FDA approval is irrespective of PD-L1 status
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 11.1 months 2-year OS: 20.0%
- OS Gain
- 3.6 months 2-year OS gain: 15.4%
- OS HR
- 0.62 (0.46-0.84)
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.
The licensed indication is for CPS PD-L1 expression ≥1. This score relates to a planned subgroup illustrating enhanced benefit among a subset of the approved cohort with CPS PD- L1 expression ≥20.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 385
- 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.