HER2 in oesophageal cancer
3 EU-approved indications in oesophageal cancer need a HER2 result: pembrolizumab (1st line, advanced), trastuzumab (1st line, metastatic) and trastuzumab deruxtecan (2nd line, advanced).
Histology
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| HER23 | ||||
Keytruda | PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1L metastatic | Gastro-oesophageal junction adenocarcinoma only |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | Gastro-oesophageal junction adenocarcinoma only; After prior trastuzumab-based regimen |
Tumour-agnostic approvals1
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
4 approvals for Oesophageal need no biomarker and apply whatever the result. All approvals for Oesophageal
See also
Label wording3
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.
- Trastuzumab (Herceptin, Tuznue)
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.