Therapy Detail
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| Therapy Name | Alpelisib + Everolimus |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 24 | 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). |
| Everolimus | Afinitor | RAD001|Zortress | mTORC1 Inhibitor 9 | Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative 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 E545K | estrogen-receptor positive breast cancer | predicted - sensitive | Alpelisib + Everolimus | Preclinical - Patient cell culture | Actionable | In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) inhibited cell viability of patient-derived ESR1 (ER)-positive breast cancer cells harboring PIK3CA E545K in culture (PMID: 36900375). | 36900375 |
| PIK3CA amp PTEN H123P | triple-receptor negative breast cancer | predicted - sensitive | Alpelisib + Everolimus | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) 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 | Alpelisib + Everolimus | Preclinical - Patient cell culture | Actionable | In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) 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 |
| PTEN dec exp | triple-receptor negative breast cancer | predicted - sensitive | Alpelisib + Everolimus | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) synergistically inhibited cell viability of PTEN-deficient triple-negative breast cancer patient-derived cells in culture, and led to inhibition of tumor growth in patient-derived xenograft (PDX) models (PMID: 36900375). | 36900375 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02077933 | Phase I | Alpelisib + Everolimus Alpelisib + Everolimus + Exemestane | Study of Safety and Efficacy of BYL719 With Everolimus or BYL719 With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors | Completed | USA | NLD | ITA | HUN | GBR | FRA | ESP | DEU | 1 |
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