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|Therapy Name||Trastuzumab deruxtecan + Tucatinib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Trastuzumab deruxtecan||Enhertu||DS-8201|DS8201a|T-DXd|DS-8201fam-trastuzumab deruxtecan-nxki||HER2 (ERBB2) Antibody 59 HER2 (ERBB2) Antibody-Drug Conjugate 21||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 locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, and in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy (FDA.gov).|
|Tucatinib||Tukysa||ONT-380|ARRY-380|irbinitinib||HER2 Inhibitor 38||Tukysa (tucatinib) selectivity inhibits ERBB2 (HER2), resulting in decreased proliferation and increased apoptosis in ERBB2 (HER2) expressing tumor cells (PMID: 28053022). Tukysa (tucatinib) in combination with Herceptin (trastuzumab) and Xeloda (capecitabine) is FDA approved for use in patients with advanced unresectable or metastatic ERBB2 (HER2)-positive breast cancer, including patients with brain metastasis, who have received prior anti-HER2 therapies, and in combination with Herceptin (trastuzumab) for patients with RAS wild-type ERBB2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04539938||Phase II||Trastuzumab deruxtecan + Tucatinib||A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04)||Recruiting||USA||0|