Therapy Detail

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Therapy Name Afatinib + Alpelisib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Afatinib Gilotrif BIBW 2992|Giotrif EGFR Inhibitor (Pan) 58 EGFR Inhibitor 2nd gen 5 HER inhibitor (Pan) 6 Gilotrif (afatinib) is a second-generation pan-Egfr inhibitor with activity against EGFR T790M and EGFR exon 19 and 21 deletions, and also inhibits ERBB2 (HER2), ERBB3 (HER3), ERBB4 (HER4) (PMID: 24435321, PMID: 25505694). Gilotrif (afatinib) is FDA approved for use in non-small cell lung cancer patients harboring non-resistant EGFR mutations, including exon 19 deletions, L858R, S768I, G719X, and L861Q, and for patients with metastatic squamous NSCLC (FDA.gov).
Alpelisib Piqray BYL719 PIK3CA inhibitor 21 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA amp PTEN H123P triple-receptor negative breast cancer predicted - sensitive Afatinib + Alpelisib Preclinical - Pdx & cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Gilotrif (afatinib) synergistically inhibited cell viability of patient-derived triple-negative breast cancer cells harboring PIK3CA amplification and PTEN H123P in culture, and led to inhibition of tumor growth in a patient-derived xenograft (PDX) model (PMID: 36900375). 36900375
PIK3CA H1047R estrogen-receptor positive breast cancer predicted - sensitive Afatinib + Alpelisib Preclinical - Patient cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Gilotrif (afatinib) synergistically inhibited cell viability of patient-derived ESR1 (ER)-positive breast cancer cells harboring PIK3CA H1047R and ESR1 (ER alpha) Y537S in culture (PMID: 36900375). 36900375
PIK3CA E545K estrogen-receptor positive breast cancer predicted - sensitive Afatinib + Alpelisib Preclinical - Patient cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Gilotrif (afatinib) synergistically inhibited cell viability of patient-derived ESR1 (ER)-positive breast cancer cells harboring PIK3CA E545K in culture (PMID: 36900375). 36900375

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries


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