Head and neck squamous cell carcinoma

The EU has approved 8 indications of 3 drugs in head and neck squamous cell carcinoma. 5 of them need a biomarker result: PD-L1 (5). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Disease setting

Approved indications, Head and neck squamous cell carcinoma
DrugBiomarker requirementRegimenSettingConditions
PD-L15
CPS ≥ 1
Monotherapy
Neoadj.
locally adv.
Then adjuvant pembrolizumab + radiation therapy with or without concomitant cisplatin, followed by monotherapy after surgery
CPS ≥ 1
+ radiation therapy with or without concomitant cisplatin, followed by monotherapy
Adj.
locally adv.
After neoadjuvant pembrolizumab and surgical resection
CPS ≥ 1
+ platinum and 5-fluorouracil (5-FU) chemotherapy
1L
advanced
None
CPS ≥ 1
Monotherapy
1L
advanced
None
TPS ≥ 50%
Monotherapy
2L
advanced
Progressing on or after platinum-containing chemotherapy
No biomarker required3
Nivolumab
Opdivo
None
Monotherapy
2L
advanced
Progressing on or after platinum-based therapy
Cetuximab
Erbitux
None
+ platinum-based chemotherapy
Any line
advanced
None
Cetuximab
Erbitux
None
+ radiation therapy
Any line
locally adv.
None

Tumour-agnostic approvals6

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
EpCAM1
Monotherapy
2L
Malignant ascites; not eligible for further systemic anticancer therapy
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options
NTRK fusion3
Entrectinib
Rozlytrekconditional
Monotherapy
Any line
No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Larotrectinib
Vitrakviconditional
Monotherapy
Any line
Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib
Augtyroconditional
Monotherapy
Any line
advanced
Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older
RET fusion1
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Biomarkers in head and neck squamous cell carcinoma

Label wording8

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Pembrolizumab (Keytruda)
    KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
  2. Pembrolizumab (Keytruda)
    KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
  3. Pembrolizumab (Keytruda)
    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 (see section 5.1).
  4. Pembrolizumab (Keytruda)
    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 (see section 5.1).
  5. Pembrolizumab (Keytruda)
    KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1).
  6. Nivolumab (Opdivo)
    OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).
  7. Cetuximab (Erbitux)
    • in combination with radiation therapy for locally advanced disease,
  8. Cetuximab (Erbitux)
    • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.