Therapy Detail

Therapy Name Everolimus + Ribociclib
Synonym
Therapy Description

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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 8 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 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
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
Clinical Trial Phase Therapies Title Recruitment Status
NCT03387020 Phase I Ribociclib Everolimus + Ribociclib Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors 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) Recruiting
NCT03834740 Phase I Everolimus + Ribociclib Ph0/2 Ribociclib & Everolimus Recruiting
NCT02985125 Phase Ib/II Everolimus + Ribociclib LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy Active, not recruiting
NCT03070301 Phase II Everolimus + Ribociclib A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors Recruiting
NCT03114527 Phase II Everolimus + Ribociclib Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Recruiting