Therapy Detail

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Therapy Name Ribociclib
Synonyms
Therapy Description

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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ribociclib Kisqali LEE011 CDK4/6 Inhibitor 13 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN loss breast cancer predicted - resistant Ribociclib Preclinical - Cell culture Actionable In a preclinical study, treatment with Kisqali (ribociclib) resulted in a decreased response in two PTEN-deficient breast cancer cell lines in culture compared to control cells and resistance in a cell-line xenograft model (PMID: 31594766). 31594766
PIK3CA H1047R oral squamous cell carcinoma decreased response Ribociclib Preclinical - Cell culture Actionable In a preclinical study, oral squamous cell carcinoma cells expressing PIK3CA H1047R demonstrated reduced sensitivity to Kisqali (ribociclib) treatment compared to cells expressing wild-type PIK3CA in culture (PMID: 31516747). 31516747
NRAS Q61L PIK3CA E545K melanoma predicted - resistant Ribociclib Preclinical - Cell culture Actionable In a preclinical study, a melanoma cell line harboring NRAS Q61L and expressing PIK3CA E545K was resistant to treatment with Kisqali (ribociclib) in culture (PMID: 29496665). 29496665
NRAS Q61K PIK3CA E545K melanoma predicted - sensitive Ribociclib Preclinical - Cell culture Actionable In a preclinical study, a melanoma cell line harboring NRAS Q61K and expressing PIK3CA E545K was resistant to treatment with Kisqali (ribociclib) in culture (PMID: 29496665). 29496665
RB1 positive Advanced Solid Tumor predicted - sensitive Ribociclib Phase I Actionable In a Phase I clinical trial, Kisqali (ribociclib) demonstrated safety and preliminary efficacy in patients with RB1-positive solid tumors and lymphomas, resulting in partial responses in 2.3% (3/132) of patients and stable disease in 32.6% (41/132) of patients, including 8 patients demonstrating stable disease for greater than 6 months (PMID: 27542767, PMID: 24795392). detail... 24795392 27542767
CDKN2A del RB1 pos glioblastoma predicted - sensitive Ribociclib Phase 0 Actionable In a Phase 0 trial, Kisqali (ribociclib) demonstrated good CNS penetration and inhibited Rb1 phosphorylation and tumor cell proliferation, resulted in a median progression-free survival of 9.7 weeks and a median overall survival of 7.8 months in patients (n=6) with recurrent glioblastoma with intact Rb1 expression and harboring deletion of CDKN2A or amplification of CDK4 or CDK6 (PMID: 31285369; NCT02933736). 31285369
CDKN2A loss Advanced Solid Tumor no benefit Ribociclib Clinical Study Actionable In a combined analysis of 2 clinical trials (DRUP, MoST), Ibrance (palbociclib) or Kisqali (ribociclib) monotherapy had limited efficacy and resulted in no objective responses, a 15% clinical benefit rate at 16 weeks, median progression-free survival of 4 mo, and median overall survival of 5 mo in previously treated advanced solid tumor patients (n=112) with CDKN2A loss, CDK4, CDK6, CCND1, CCND2, or CCND3 amplification, or inactivating SMARCA4 mutations (PMID: 37424386; NCT02925234, ACTRN12616000931471). 37424386

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02187783 Phase II Ribociclib LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) Completed USA 0
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Active, not recruiting USA 0
NCT04585724 Phase I Abemaciclib Palbociclib Ribociclib Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases Withdrawn 0
NCT05452213 FDA approved Ribociclib Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients (CAPTOR-BC) Recruiting DEU 0
NCT03387020 Phase I Ribociclib Everolimus + Ribociclib Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors Completed USA 0
NCT02934568 Phase II Ribociclib Ribociclib (LEE011) Rollover Study for Continued Access Recruiting USA | FRA | ESP 2
NCT02607124 Phase Ib/II Ribociclib Administration of Ribociclib Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) Terminated USA 0
NCT05296746 Phase II Ribociclib Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer (RIBOLARIS) Recruiting FRA | ESP 1
NCT04801966 Phase 0 Palbociclib Alpelisib Atezolizumab Vemurafenib Ribociclib Talazoparib Cobimetinib Trametinib Abemaciclib Dabrafenib Nivolumab Binimetinib Pembrolizumab Encorafenib Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study (TAILOR) Terminated AUS 0
NCT02524119 Phase II Ribociclib LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) Terminated USA 0
NCT03477396 Phase II Ribociclib Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer Active, not recruiting USA 0
NCT05996107 Phase I Ribociclib Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer Not yet recruiting USA 0
NCT05161195 FDA approved Fulvestrant + Ribociclib Ribociclib Ribociclib + Tamoxifen Goserelin + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Roll-over Study to Allow Continued Access to Ribociclib Recruiting USA | ITA | ESP 15
NCT01237236 Phase I Ribociclib A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. Completed USA | FRA 1
NCT02555189 Phase Ib/II Ribociclib Enzalutamide Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression Active, not recruiting USA 0
NCT03179956 Phase I Ribociclib Impact of Ribociclib on Head and Neck Squamous Cell Cancer Terminated USA 0
NCT03701334 Phase III Ribociclib A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 10
NCT02035813 Phase II Ribociclib Eribulin DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). Active, not recruiting DEU 0
NCT04055493 Phase III Ribociclib Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle) Recruiting DEU 0
NCT02300987 Phase II Ribociclib A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression Completed USA | FRA | ESP 1
NCT01747876 Phase I Ribociclib Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma Terminated USA | GBR | FRA | DEU | AUS 0
NCT03285412 Phase II Ribociclib CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (LEADER) Recruiting USA 0
NCT05664893 Phase Ib/II Ribociclib Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS) (CALHYS) Recruiting FRA 0
NCT02345824 Phase I Ribociclib Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma Unknown status USA 0
NCT04417621 Phase II LTT462 + LXH 254 Trametinib Ribociclib Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma Active, not recruiting USA | ITA | GBR | FRA | DEU | BEL | AUS 5
NCT02420691 Phase II Ribociclib LEE011 in Neuroendocrine Tumors of Foregut Origin Completed USA 0
NCT02657343 Phase Ib/II Ribociclib Trastuzumab Ado-trastuzumab emtansine An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer. Completed USA 0
NCT03078751 Phase II Ribociclib Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) Completed USA 0


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