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|Therapy Name||Alpelisib + Infigratinib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Alpelisib||Piqray||BYL719||PIK3CA inhibitor 16||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).|
|Infigratinib||BGJ398|BGJ-398|BGJ 398||FGFR Inhibitor (Pan) 18||Infigratinib (BGJ398) is pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (PMID: 31109923, PMID: 30101387).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FGFR3 - TACC3||transitional cell carcinoma||predicted - sensitive||Alpelisib + Infigratinib||Phase I||Actionable||In a Phase Ib trial, Infigratinib (BGJ398) and Alpelisib (BYL719) combination treatment resulted in partial response and a complete shrinkage of target lesions lasting 4 months in one urothelial carcinoma patient harboring a FGFR3-TACC3 fusion (J Clin Oncol 34, 2016 (suppl; abstr 2500)).||detail...|
|Unknown unknown||Advanced Solid Tumor||not applicable||Alpelisib + Infigratinib||Phase I||Actionable||In a Phase Ib trial, Infigratinib (BGJ398) and Alpelisib (BYL719) combination treatment resulted in partial response in 25% (8/32) of patients with advanced solid tumors, including urothelial, head and neck, melanoma, and anal cancer (J Clin Oncol 34, 2016 (suppl; abstr 2500)).||detail...|
|PIK3CA mutant||Advanced Solid Tumor||no benefit||Alpelisib + Infigratinib||Phase Ib/II||Actionable||In a Phase Ib trial, treatment with the combination of Piqray (alpelisib) and Infigratinib (BGJ398) resulted in partial response (PR) in 9.7% (6/62) and disease control (PR or stable disease) in 61.3% (34/62) of patients with advanced solid tumors harboring a PIK3CA mutation with or without an FGFR alteration, however, the efficacy was not deemed great enough to pursue further development (JCO Precision Oncology 2019 :3, 1-13).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT01928459||Phase I||Alpelisib + Infigratinib||Phase 1b Trial of BGJ398/BYL719 in Solid Tumors||Completed|