Therapy Detail

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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
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
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
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
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
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

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02933736	Phase 0	Ribociclib	Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients	Active, not recruiting	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 \| ROU \| POL \| ITA \| IRL \| HUN \| GBR \| FRA \| ESP \| DEU \| CAN \| BRA \| BEL \| AUT \| AUS \| ARG	4
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
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
NCT05161195	FDA approved	Fulvestrant + Ribociclib Ribociclib Ribociclib + Tamoxifen Goserelin + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib	Roll-over Study to Allow Continued Access to Ribociclib	Active, not recruiting	USA \| TUR \| POL \| LBN \| ITA \| GRC \| ESP \| BRA \| ARG	13
NCT01237236	Phase I	Ribociclib	A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.	Completed	USA \| NLD \| FRA	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
NCT02187783	Phase II	Ribociclib	LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)	Completed	USA	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
NCT02420691	Phase II	Ribociclib	LEE011 in Neuroendocrine Tumors of Foregut Origin	Completed	USA	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
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
NCT03387020	Phase I	Ribociclib Everolimus + Ribociclib	Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors	Completed	USA	0
NCT03477396	Phase II	Ribociclib	Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer	Completed	USA	0
NCT02934568	Phase II	Ribociclib	Ribociclib (LEE011) Rollover Study for Continued Access	Recruiting	USA \| FRA \| ESP	2
NCT03285412	Phase II	Ribociclib	CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (LEADER)	Recruiting	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
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
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
NCT05996107	Phase I	Ribociclib	Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer	Recruiting	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
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
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
NCT02524119	Phase II	Ribociclib	LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001)	Terminated	USA	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
NCT03179956	Phase I	Ribociclib	Impact of Ribociclib on Head and Neck Squamous Cell Cancer	Terminated	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
NCT02345824	Phase I	Ribociclib	Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma	Unknown status	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

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