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

Prescribing Information

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

Helping to redefine survival expectations for your first-line metastatic or unresectable recurrent (M/uR) HNSCC patients with PD-L1 expression CPS ≥11

For use in

First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).1

Patient

Suitable adults whose tumours express PD-L1 with a CPS ≥1.1

Testing

To prescribe KEYTRUDA, patients require timely validated PD-L1 testing, appropriate CPS evaluation and clinical considerations as per SmPC to inform treatment options.

Recommended Treatment approach as per SmPC

  • Monotherapy (fixed dose regimen Q3W (200mg) or Q6W (400mg) intravenously over 30 minutes),1 or;
  • In combination with platinum and 5-fluorouracil (5-FU) chemotherapy (fixed dose regimen Q3W (200mg) intravenously over 30 minutes).1

Download the full presentation slides for the KEYNOTE-048 clinical study

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

Download (5.87MB)

Abbreviations

5-FU: 5 fluorouracil CPS: combined positive score
HNSCC: head and neck squamous cell carcinoma
M/uR: metastatic or unresectable recurrent
PD-L1: programmed death-ligand 1
QxW: x-weekly dosing

References

  1. KEYTRUDA Summary of Product Characteristics.

Supporting documentation

GB-OHN-00197 | Date of Preparation: July 2020