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KEYTRUDA (pembrolizumab) HNSCC /
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KEYTRUDA® (pembrolizumab) in first-line head & neck squamous cell carcinoma (HNSCC)

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

Changing your treatment outlook could change his survival outcomes

For eligible patients, start with KEYTRUDA (pembrolizumab) an anti-PD-1 therapy approved for first-line treatment of M/uR HNSCC in the UK1

Use the treatment algorithm below, which is adapted from ESMO guidelines, to explore the potential of KEYTRUDA in metastatic or unresectable recurrent HNSCC patients with PD-L1 expression of CPS ≥ 1.2

Diagnosis
Curative
Palliative
Early stage
Locally advanced
Recurrent/metastatic
PALLIATIVE SETTING
Recurrent/metastatic disease not amenable to curative intent
PD-L1 CPS ≥ 1
PD-L1 CPS negative
First line
KEYTRUDA monotherapy
funded by NICE & SMC3-5
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KEYTRUDA plus chemotherapy
funded by SMC only5
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Chemotherapy

Cetuximab plus chemotherapy funded by NICE for cancer that started in the oral cavity only6,7
Other licensed treatment options available
Subsequent lines
Licensed treatment options available
include, but are not limited to:
Chemotherapy
Cetuximab plus chemotherapy funded by NICE for cancer that started
in the oral cavity only6,7
Best supportive care
Progressive disease/recurrence occured within 6 months of last dose of platinum based chemotherapy
PD-L1 TPS3
Nivolumab8
funded by NICE & SMC9,10

This treatment algorithm has been adapted from Figure 5, ESMO guidelines for the management of recurrent and/or metastatic disease not amenable to curative radiotherapy or surgery and adapted for relevance to UK funding.2 For full HNSCC management guidelines please refer to the full ESMO guidelines.2 Refer to the appropriate SmPC before prescribing any product to minimise adverse events.

View references

Discover how KEYTRUDA (pembrolizumab) could change your
M/uR HNSCC patients’ survival outcomes

KEYTRUDA monotherapy outcomes

(KEYNOTE-048 results)

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KEYTRUDA plus chemotherapy outcomes

(KEYNOTE-048 results)

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KEYNOTE 048 slide deck on KEYTRUDA (pembrolizumab) plus or minus chemotherapy vs EXTREME in first-line HNSCC
Rating

Discover all the data for KEYTRUDA in M/uR HNSCC (KEYNOTE-048 full results slide deck)

 

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

Licensed indication
NICE recommendations
SMC recommendations

KEYTRUDA, as monotherapy or 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 ≥ 1.1

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

KEYTRUDA monotherapy is recommended as an option for untreated metastatic or unresectable recurrent HNSCC, in adults whose tumours express PD-L1 with a CPS ≥ 1, regardless of where the cancer started.4

KEYTRUDA should be stopped at 2 years of uninterrupted treatment, or earlier if disease progresses.4

This advice applies only if the company provides KEYTRUDA according to the commercial arrangement.4

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KEYTRUDA is accepted for restricted use within NHS Scotland.5

In Scotland, KEYTRUDA can be used as a monotherapy or in combination with 5-FU chemotherapy for first-line treatment of M/uR HNSCC in adults whose tumours express PD-L1 with a CPS ≥ 1.5

This advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.5

Treatment with KEYTRUDA is subject to a 2-year clinical stopping rule.5

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PD-L1 testing supports a targeted treatment approach for all appropriate patients with M/uR HNSCC*1

CPS ≥ 1 in the KEYNOTE-048 study1

Icons representing the 85% of patients with HNSCC in KEYNOTE 048 who had tumours expressing PD-L1 with a CPS ≥ 1

85%

(n=754/882) of treatment-naïve patients with M/uR HNSCC had tumours that expressed PD-L1 (CPS ≥ 1)11,12

*The KEYNOTE-048 study employed the PD-L1 IHC 22C3 pharmDx assay (Agilent Technologies, Carpinteria, CA, USA)1,11

To find out more about the different types of patients who could benefit from KEYTRUDA, arrange a discussion with an MSD representative

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Abbreviations

5-FU, 5-fluorouracil; CPS, combined positive score; ESMO, European Society for Medical Oncology; HNSCC, head and neck squamous cell carcinoma; M/uR, metastatic or unresectable recurrent; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PAS, Patient Access Scheme; PD-1, programmed cell death-1; PD-L1, programmed death ligand-1; SmPC, Summary of Product Characteristics; SMC, Scottish Medicines Consortium; TPS, tumour proportion score.

References

  1. KEYTRUDA (pembrolizumab) Summary of Product Characteristics.
  2. Machiels J-P et al. Ann Oncol 2020;31:1462–75.
  3. National Cancer Drugs Fund List ver1.181 02-Aug-21 HNSCC.
    Available at https://www.england.nhs.uk/publication/national-cancer-drugs-fund-list/
  4. NICE TA661 pembrolizumab.
    Available at https://www.nice.org.uk/guidance/ta661/chapter/1-Recommendations
  5. SMC advice. Pembrolizumab (KEYTRUDA).
    Available at: https://www.scottishmedicines.org.uk/media/5369/pembrolizumab-keytruda-hnscc-final-august-2020docx-for-website.pdf
  6. Erbitux (cetuximab) Summary of Product Characteristics.
  7. NICE TA473 cetuximab.
    Available at https://www.nice.org.uk/guidance/ta473/chapter/1-Recommendations
  8. Opdivo (nivolumab) Summary of Product Characteristics.
  9. NICE TA490 nivolumab.
    Available at: https://www.nice.org.uk/guidance/ta490/chapter/1-Recommendations
  10. SMC nivolumab.
    Available at https://www.scottishmedicines.org.uk/medicines-advice/nivolumab-opdivo-fullsubmission-126117/
  11. Agilent. PD-L1 IHC 22C3 pharmDx Interpretation Manual – HNSCC.
  12. Burtness B et al. Lancet 2019:394;1915–28.

GB-OHN-00356 | Date of Preparation: November 2021