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|LEE-011|LEE 011 | CDK4/6 Inhibitor 14 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | TUR | POL | LBN | ITA | GRC | ESP | BRA | ARG | 12 |
| NCT02934568 | Phase II | Ribociclib | Ribociclib (LEE011) Rollover Study for Continued Access | Recruiting | USA | FRA | ESP | 2 |
| NCT03078751 | Phase II | Ribociclib | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) | Completed | 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 |
| 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 | NLD | FRA | ESP | 0 |
| NCT01237236 | Phase I | Ribociclib | A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. | Completed | USA | NLD | FRA | 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 | Suspended | USA | 0 |
| NCT03387020 | Phase I | Ribociclib Everolimus + Ribociclib | Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors | Completed | 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 |
| 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 |
| NCT04055493 | Phase III | Ribociclib | Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle) | Active, not recruiting | DEU | 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 | ROU | POL | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
| NCT02345824 | Phase I | Ribociclib | Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma | Unknown status | USA | 0 |
| 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). | Completed | DEU | 0 |
| NCT03179956 | Phase I | Ribociclib | Impact of Ribociclib on Head and Neck Squamous Cell Cancer | Terminated | 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 |
| 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 |
| 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 |
| NCT06044623 | Phase III | Exemestane Abemaciclib Palbociclib Ribociclib Letrozole Anastrozole Fulvestrant | Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients (IMPORTANT) | Recruiting | SWE | NOR | ITA | GRC | FIN | ESP | 0 |
| NCT02555189 | Phase Ib/II | Ribociclib Enzalutamide | Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression | Completed | USA | 0 |
| NCT02187783 | Phase II | Ribociclib | LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) | Completed | USA | 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 |
| 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 | |
| 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 | NOR | NLD | ITA | ISR | GBR | FRA | DEU | CHE | BEL | AUS | ARG | 0 |
| NCT02420691 | Phase II | Ribociclib | LEE011 in Neuroendocrine Tumors of Foregut Origin | Completed | USA | 0 |
| NCT06380751 | Phase III | Ribociclib Fulvestrant Camizestrant + Saruparib Anastrozole Camizestrant + Ribociclib Letrozole Camizestrant + Palbociclib Abemaciclib + Camizestrant Exemestane Abemaciclib Palbociclib | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (EvoPAR-BR01) | Recruiting | USA | TUR | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 11 |
| 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 | Completed | USA | 0 |
| NCT03285412 | Phase II | Ribociclib | CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (LEADER) | Recruiting | USA | 0 |
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