PD-L1 in oesophageal cancer
10 EU-approved indications in oesophageal cancer need a PD-L1 result: pembrolizumab (1st line, advanced), pembrolizumab (1st line, advanced), pembrolizumab (1st line, advanced), nivolumab (1st line, advanced), nivolumab (1st line, advanced), nivolumab (1st line, advanced), serplulimab (1st line, advanced), tislelizumab (1st line, advanced), tislelizumab (1st line, advanced) and ipilimumab (1st line, advanced).
Histology
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PD-L110 | ||||
Yervoy | Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1L advanced | Squamous cell carcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Squamous cell carcinoma only |
Opdivo | CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Adenocarcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + ipilimumab | 1L advanced | Squamous cell carcinoma only |
Keytruda | CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Keytruda | CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Hetronifly | CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
Tevimbra | TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Tevimbra | TAP score ≥ 5% | + platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
4 approvals for Oesophageal need no biomarker and apply whatever the result. All approvals for Oesophageal
See also
Label wording10
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
- Serplulimab (Hetronifly)
HETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).
- Ipilimumab (Yervoy)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.