PD-L1 in head and neck squamous cell carcinoma
5 EU-approved indications in head and neck squamous cell carcinoma need a PD-L1 result: pembrolizumab (neoadjuvant, locally advanced), pembrolizumab (adjuvant, locally advanced), pembrolizumab (1st line, advanced), pembrolizumab (1st line, advanced) and pembrolizumab (2nd line, advanced).
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PD-L15 | ||||
Keytruda | CPS ≥ 1 | Monotherapy | Neoadj. locally adv. | Then adjuvant pembrolizumab + radiation therapy with or without concomitant cisplatin, followed by monotherapy after surgery |
Keytruda | CPS ≥ 1 | + radiation therapy with or without concomitant cisplatin, followed by monotherapy | Adj. locally adv. | After neoadjuvant pembrolizumab and surgical resection |
Keytruda | CPS ≥ 1 | + platinum and 5-fluorouracil (5-FU) chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1 | Monotherapy | 1L advanced | None |
Keytruda | TPS ≥ 50% | Monotherapy | 2L advanced | Progressing on or after platinum-containing chemotherapy |
3 approvals for HNSCC need no biomarker and apply whatever the result. All approvals for HNSCC
See also
Label wording5
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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.
- 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.
- 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).
- 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).
- 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).