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Therapy Detail
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| Therapy Name | ELVN-002 + Trastuzumab deruxtecan |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| ELVN-002 | ELVN002|ELVN 002 | HER2 Inhibitor 43 | ELVN-002 selectively inhibits ERBB2 (HER2), including mutant ERBB2 (HER2), potentially leading to decreased tumor cell proliferation and reduced growth of ERBB2 (HER2)-expressing and ERBB2 (HER2)-mutant tumors (Cancer Res (2023) 83 (7_Supplement): 4019). | |
| Trastuzumab deruxtecan | Enhertu | DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a | HER2 (ERBB2) Antibody 77 HER2 (ERBB2) Antibody-Drug Conjugate 33 | Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with ERBB2 (HER2)-low or untra-low (IHC 0 with membrane staining) hormone receptor-positive breast cancer who had received endocrine therapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, and in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05650879 | Phase I | ELVN-002 ELVN-002 + Trastuzumab deruxtecan Ado-trastuzumab emtansine + ELVN-002 | ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (HER2) | Recruiting | USA | ITA | FRA | ESP | AUS | 2 |
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