4
Indication details
- Control Arm
- Cisplatin or carboplatin/5-FU/cetuximab
- Therapeutic Indication
- As monotherapy 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 approval June 2019
- EMA Approval
- EMA (CHMP) August 2019 EC decision October 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 10.8 months 2-year OS: 19.7%
- OS Gain
- 4.1 months 2-year OS gain: 15.6%
- OS HR
- 0.61 (0.46-0.81)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
Toxicity was reduced for pembro vs control in the whole population. No information is provided for the cohorts of interest. Thus, no upgrade should be implemented
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Comment
-
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.
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
- 196
- Scorecard version
- 1
- Issue date
- 17.07.2020
- Last update
- 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.