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4

Indication details

Combined Agent(s)
Cisplatin or carboplatin/5-FU
Control Arm
Cisplatin or carboplatin/5-FU/cetuximab
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 ≥1
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
10.6 months 2-year OS: 17.1%
OS Gain
3.0 months 2-year OS gain: 13.7%
OS HR
0.64 (0.53-0.78)

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
197
Scorecard version
1
Issue date
20.07.2020
Last update
07.08.2023
Pembrolizumab KEYNOTE-048

PRELIMINARY SCORE

OS

ADJUSTMENTS

No QoL benefit
Pembrolizumab KEYNOTE-048

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
4
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Head and neck cancer
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
Pembrolizumab + Cisplatin or carboplatin/5-FU
Cisplatin or carboplatin/5-FU/cetuximab

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