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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||Truseltiq||BGJ398|BGJ-398|BGJ 398||FGFR Inhibitor (Pan) 19||Truseltiq (infigratinib) is a pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (PMID: 31109923, PMID: 30101387). Truseltiq (infigratinib) is FDA approved for use in patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FGFR2 N550K PIK3CA I20M PIK3CA P539R PTEN R130Q PTEN T321fs||endometrial cancer||sensitive||Alpelisib + Infigratinib||Preclinical - Cell culture||Actionable||In a preclinical study, the combination of Truseltiq (infigratinib) and Alpelisib (BYL719) resulted in a synergistic effect, demonstrating inhibition of cell proliferation and induced cell death in an endometrial cancer cell line harboring FGFR2 N550K, PIK3CA I20M and P539R, and PTEN R130Q and T321fs*23 in culture (PMID: 28119489).||28119489|
|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 Truseltiq (infigratinib) 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...|
|FGFR3 - TACC3||transitional cell carcinoma||predicted - sensitive||Alpelisib + Infigratinib||Phase I||Actionable||In a Phase Ib trial, Truseltiq (infigratinib) 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...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT01928459||Phase I||Alpelisib + Infigratinib||Phase 1b Trial of BGJ398/BYL719 in Solid Tumors||Completed||USA | CAN||10|