# 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).

## Approved indications

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1st line, advanced | Squamous cell carcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | Squamous cell carcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | Adenocarcinoma only |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | + ipilimumab | 1st line, advanced | Squamous cell carcinoma only |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | Gastro-oesophageal junction adenocarcinoma only |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | Gastro-oesophageal junction adenocarcinoma only |
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | PD-L1 CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | Gastro-oesophageal junction adenocarcinoma only |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 TAP score ≥ 5% | + platinum-based chemotherapy | 1st line, advanced | Squamous cell carcinoma only |

## Label wording

- **Pembrolizumab** (Keytruda), Oesophageal cancer, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “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%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “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%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Oesophageal cancer, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Gastric and GEJ adenocarcinoma, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Oesophageal cancer, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Oesophageal cancer, 1st line, advanced: “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%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/oesophageal-cancer/pd-l1