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|Therapy Name||Alpelisib + Cetuximab + Radiotherapy|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Alpelisib||Piqray||BYL719||PIK3CA inhibitor 18||Piqray (alpelisib) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034). Piqray (alpelisib) is FDA approved in combination with fulvestrant for use in postmenopausal women, and men, with advanced or metastatic hormone receptor (HR)-positive, ERBB2 (HER2)-negative, PIK3CA-mutant breast cancer (FDA.gov).|
|Cetuximab||Erbitux||IMC-C225||EGFR Antibody 42||Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|PIK3CA E542K||head and neck squamous cell carcinoma||predicted - sensitive||Alpelisib + Cetuximab + Radiotherapy||Case Reports/Case Series||Actionable||In a Phase Ib trial, 11 of 11 patients with metastatic head and neck squamous cell carcinoma demonstrated no evidence of disease at 3 to 4 months following treatment with Piqray (alpelisb) in combination with Erbitux (cetuximab) and intensity modulated radiation therapy (IMRT), and PIK3CA E545K was identified in one patient with oropharyngeal squamous cell carcinoma who had a near complete radiologic response within 8 days of starting IMRT (PMID: 31678634).||31678634|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|