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|Therapy Name||Everolimus + Ribociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Everolimus||Afinitor||RAD001|Zortress||mTORC1 Inhibitor 8||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).|
|Ribociclib||Kisqali||LEE011||CDK4/6 Inhibitor 10||Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|NOTCH1 wild-type RB1 wild-type||T-cell adult acute lymphocytic leukemia||sensitive||Everolimus + Ribociclib||Preclinical - Cell line xenograft||Actionable||In a preclinical study, the combination of Kisqali (ribociclib) and Afinitor (everolimus) treatment in a T-cell acute lymphoblastic leukemia cell line harboring wild-type RB1 and wild-type NOTCH1 resulted in decreased Rb1 phosphorylation and a greater inhibition of cell growth compared to either agent alone in culture, and prolonged survival in cell-line xenograft models (PMID: 28151717).||28151717|
|Unknown unknown||pancreatic adenocarcinoma||no benefit||Everolimus + Ribociclib||Phase I||Actionable||In a Phase I trial, treatment with the combination of Afinitor (everolimus) and Kisqali (ribociclib) did not lead to a clinical benefit in pancreatic adenocarcinoma patients who previously progressed on chemotherapy (n=11), resulting in a median progression-free survival of 1.8 months, a median overall survival of 3.7 months, stable disease in two patients for 8 weeks, and progressive disease in nine patients (PMID: 32642630; NCT02985125).||32642630|
|NOTCH1 mut RB1 wild-type||T-cell adult acute lymphocytic leukemia||sensitive||Everolimus + Ribociclib||Preclinical - Cell culture||Actionable||In a preclinical study, the combination of Kisqali (ribociclib) and Afinitor (everolimus) treatment in a T-cell acute lymphoblastic leukemia cell line harboring wild-type RB1 and a NOTCH1 mutation resulted in decreased Rb1 phosphorylation and a greater inhibition of cell growth compared to either agent alone in culture (PMID: 28151717).||28151717|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT02985125||Phase Ib/II||Everolimus + Ribociclib||LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy||Active, not recruiting|
|NCT03387020||Phase I||Ribociclib Everolimus + Ribociclib||Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors||Completed|
|NCT03114527||Phase II||Everolimus + Ribociclib||Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)||Recruiting|
|NCT03834740||Phase I||Everolimus + Ribociclib||A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection||Recruiting|
|NCT03355794||Phase I||Everolimus + Ribociclib||A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)||Active, not recruiting|
|NCT03070301||Phase II||Everolimus + Ribociclib||A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors||Active, not recruiting|