Therapy Detail
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| Therapy Name | Alpelisib + Nintedanib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 23 | 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). |
| Nintedanib | Ofev | BIBF 1120|Vargatef|BIBF 1120 | FGFR Inhibitor (Pan) 26 PDGFR Inhibitor (Pan) 30 RET Inhibitor 52 VEGFR Inhibitor (Pan) 36 | Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR3 K652E PIK3CA P124L | urinary bladder cancer | sensitive | Alpelisib + Nintedanib | Preclinical - Cell culture | Actionable | In a preclinical study, combination treatment with Ofev (nintedanib) and Piqray (alpelisib) led to synergistic inhibition of growth in a bladder cancer cell line harboring FGFR3 K652E and PIK3CA P124L in culture (PMID: 36805958). | 36805958 |
| PIK3CA E542Q PIK3CA E674Q | urinary bladder cancer | sensitive | Alpelisib + Nintedanib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, combination treatment with Ofev (nintedanib) and Piqray (alpelisib) led to synergistic inhibition of growth in bladder cancer cell lines harboring PIK3CA E542Q and PIK3CA E674Q in culture, and led to inhibition of tumor growth in a cell line xenograft model (PMID: 36805958). | 36805958 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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