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 9 | 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 |
|---|---|---|---|---|---|---|---|
| NOTCH1 wild-type RB1 wild-type | T-cell adult acute lymphocytic leukemia | sensitive | Ribociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a T-cell acute lymphoblastic leukemia cell line harboring wild-type RB1 and wild-type NOTCH1 demonstrated sensitivity to treatment with Kisqali (ribociclib) in culture, resulting in inhibition of cell growth (PMID: 28151717). | 28151717 |
| 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 |
| NOTCH1 mut RB1 wild-type | T-cell adult acute lymphocytic leukemia | sensitive | Ribociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a T-cell acute lymphoblastic leukemia cell line co-harboring wild-type RB1 and a NOTCH1 mutation demonstrated sensitivity to treatment with Kisqali (ribociclib) in culture, resulting in inhibition of cell growth (PMID: 28151717). | 28151717 |
| Unknown unknown | neuroblastoma | not applicable | Ribociclib | Phase I | Actionable | In a Phase I trial, Kisqali (ribociclib) treatment demonstrated safety and resulted in stable disease in 28% (9/32) of pediatric patients with neuroblastoma or malignant rhabdoid tumor (MRT) (7 patients with neuroblastoma and 2 with CNS primary MRT), and 5 patients demonstrated stable disease for greater than 6 months (PMID: 28432176). | 28432176 |
| 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 multiforme | predicted - sensitive | Ribociclib | Phase 0 | Actionable | In a Phase 0 trial, Kisqali (ribociclib) demonstrated good CNS penetration and inhibited Rb1 phoaphorylation and tumor cell proliferation, resulted in a median progression-free survival of 9.7 week and an 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 |
| NOTCH1 wild-type RB1 loss | T-cell adult acute lymphocytic leukemia | resistant | Ribociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a T-cell acute lymphoblastic leukemia cell line harboring wild-type NOTCH1 and loss of RB1 demonstrated resistance to Kisqali (ribociclib) in culture, resulting in limited inhibition of cell growth (PMID: 28151717). | 28151717 |
| Unknown unknown | rhabdoid cancer | not applicable | Ribociclib | Phase I | Actionable | In a Phase I trial, Kisqali (ribociclib) treatment demonstrated safety and resulted in stable disease in 28% (9/32) of pediatric patients with neuroblastoma or malignant rhabdoid tumor (MRT) (7 patients with neuroblastoma and 2 with CNS primary MRT), and 5 patients demonstrated stable disease for greater than 6 months (PMID: 28432176). | 28432176 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| 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) | Recruiting |
| 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. | Active, not recruiting |
| NCT02345824 | Phase I | Ribociclib | Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma | Unknown status |
| NCT02524119 | Phase II | Ribociclib | LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) | Recruiting |
| NCT02420691 | Phase II | Ribociclib | LEE011 in Neuroendocrine Tumors of Foregut Origin | Completed |
| NCT02934568 | Phase II | Ribociclib | Ribociclib (LEE011) Rollover Study for Continued Access | Recruiting |
| NCT01747876 | Phase I | Ribociclib | Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma | Terminated |
| NCT01237236 | Phase I | Ribociclib | A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. | Completed |
| NCT02933736 | Phase 0 | Ribociclib | Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients | Recruiting |
| NCT03179956 | Phase I | Ribociclib | Impact of Ribociclib on Head and Neck Squamous Cell Cancer | Terminated |
| NCT02555189 | Phase Ib/II | Ribociclib Enzalutamide | Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression | Recruiting |
| NCT03285412 | Phase II | Ribociclib | CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) | Active, not recruiting |
| 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) | Unknown status |
| NCT02187783 | Phase II | Ribociclib | LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) | Completed |
| NCT03477396 | Phase II | Ribociclib | Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer | Active, not recruiting |
| NCT03387020 | Phase I | Ribociclib Everolimus + Ribociclib | Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors | Completed |
| 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 |
| NCT03078751 | Phase II | Ribociclib | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) | Completed |
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