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Therapy Name Alpelisib + Infigratinib
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).
Infigratinib Truseltiq BGJ398|BGJ-398|BGJ 398 FGFR Inhibitor (Pan) 25 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).

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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...
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

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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 | ITA | FRA | ESP | DEU | CAN | BEL | AUS 4


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