PD-L1 in gastric and GEJ adenocarcinoma
4 EU-approved indications in gastric and GEJ adenocarcinoma need a PD-L1 result: pembrolizumab (1st line, advanced), pembrolizumab (1st line, advanced), nivolumab (1st line, advanced) and tislelizumab (1st line, advanced).
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PD-L14 | ||||
Opdivo | CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | None |
Tevimbra | TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | None |
4 approvals for Gastric/GEJ need no biomarker and apply whatever the result. All approvals for Gastric/GEJ
See also
Label wording4
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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 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.
- 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).