HER2 in gastric and GEJ adenocarcinoma
3 EU-approved indications in gastric and GEJ adenocarcinoma need a HER2 result: pembrolizumab (1st line, advanced), trastuzumab (1st line, metastatic) and trastuzumab deruxtecan (2nd line, advanced).
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 | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1L metastatic | None |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | 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 Gastric/GEJ need no biomarker and apply whatever the result. All approvals for Gastric/GEJ
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.