Summary of KEYTRUDA® (pembrolizumab) in first-line Head & Neck Squamous Cell Carcinoma

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.1

KEYTRUDA in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumours express PD-L1 with a CPS ≥ 1.1

Summary of KEYNOTE-048

For eligible patients, start with KEYTRUDA, the first anti-PD-1 therapy to be licensed in the first-line treatment of M/uR HNSCC in the UK1

  KEYTRUDA monotherapy vs EXTREMEa in patients with PD-L1 CPS ≥1: KEYTRUDA + chemotherapy vs EXTREMEa in patients with PD-L1 CPS ≥1:
Achieved clinical and statistical significance and superiority at OS primary endpointb 26% reduction in risk of death (HR, 0.74; 95% CI, 0.61–0.90; P=0.00133)1 35% reduction in risk of death (HR 0.65; 95% CI; 0.53–0.80; P=0.00002)1
PFS (multiple primary end points) Statistical significance not met2,3
Safety profilec in the intention to treat (ITT) population Favourable overall safety profile2,3 Comparable safety profile2,3

KEYTRUDA SmPC Dosing:1

The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.1

For full details on KEYNOTE-048 data please see the presentation below available for download, or view the SmPC: SmPC for Great Britain & SmPC for Northern Ireland [External links]

KEYNOTE-048 was a randomised, open-label, Phase III study of pembrolizumab monotherapy vs EXTREME and pembrolizumab plus chemotherapy vs EXTREME in patients with untreated locally incurable recurrent or metastatic HNSCC.

KEYNOTE-048 Slide deck

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Footnotes

aCetuximab 250 mg/m2 Q1W (following a loading dose of 400 mg/m2) + 5-FU 1000 mg/mg2/d for 4 days + carboplatin AUC 5 or cisplatin 100 mg/m2 Q3W for 6 cycles
bMedian follow-up of 11.5 months for KEYTRUDA monotherapy and median follow-up of 13.0 months for KEYTRUDA plus chemotherapy1
cAs-treated population
d400 mg Q6W dosing based on SmPC, not investigated in KEYNOTE-048

Abbreviations

AUC 5: desired carboplatin exposure of area under curve 5 mg/m2
CPS: combined positive score
EXTREME: drug regimen consisting of Cetuximab 250 mg/m2 Q1W (following a loading dose of 400 mg/m2) + 5-FU 1000 mg/m2/d for 4 days + carboplatin AUC 5 or cisplatin 100 mg/m2 Q3W for 6 cycles
HNSCC: head and neck squamous cell carcinoma
HR: hazard ratio
ITT: intention to treat
M/uR: metastatic or unresectable recurrent
OS: overall survival
PD-1: programmed cell death protein 1
PD-L1: programmed death-ligand 1
PFS: progression-free survival
QxW: x-weekly dosing

References

  1. KEYTRUDA Summary of Product Characteristics.
  2. Burtness B et al. Lancet. 2019:394;1915–28.
  3. EMA, assessment report for KEYTRUDA. EMEA/H/C/003820/II/0065. October 2019. Available from: https://www.ema.europa.eu/en/documents/variation-report/keytruda-h-c-3820-ii-0065-epar-assessment-report-variation_en.pdf.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-OHN-00353 | Date of Preparation: September 2021