LEE011

Phase 2Small molecule

Novartis

LEE011 is one of 334 small molecule programs targeting Teratoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

333

Competitors

Pipeline

Status by Indication[3][1]

Indication

TeratomaActive, not recruiting

LymphomaActive, not recruiting

Metastatic MelanomaActive, not recruiting

NeuroblastomaActive, not recruiting

LiposarcomaActive, not recruiting

MyelofibrosisActive, not recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

TeratomaPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Metastatic MelanomaPhase 2

Active, not recruiting

NeuroblastomaPhase 1

Active, not recruiting

LiposarcomaPhase 1

Active, not recruiting

MyelofibrosisPhase 1

Active, not recruiting

Pancreatic AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

MelanomaPhase 1/Phase 2

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tecentriq

Roche

Preclinical

36 2

Trodelvy

Gilead

Preclinical

37 3

Halaven

Eisai

Preclinical

38 4

Tykerb

GSK

Preclinical

80 5

LEE011

Novartis

Phase 2

6 6

Avastin

BBio-Thera Solutions

Preclinical

153 7

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 8

Adriamycin

GGynecologic Oncology Group

Preclinical

87 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

ESS

NCT02934568

Phase 1/2Active, not recruiting

Breast Cancer

NCT01872260

Clinical

Trials by Indication[1]

Breast Cancer6 trials

Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT02154776·13 enrolled

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

Terminated· Novartis logo

Novartis·Phase 2·NCT01919229·14 enrolled

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

Active, not recruiting· Novartis logo

Novartis·Phase 1/2·NCT01872260·255 enrolled

Show 3 more trials

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02088684·70 enrolled

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Terminated· Novartis logo

Novartis·Phase 1·NCT02734615·199 enrolled

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02333370·88 enrolled

Melanoma3 trials

A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma

Completed· Pfizer logo

Pfizer·Phase 1/2·NCT01781572·102 enrolled

LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma

Completed· Pfizer logo

Pfizer·Phase 2·NCT02159066·158 enrolled

Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

Terminated·UUnknown Sponsor·Phase 1/2·NCT01777776·28 enrolled

Tumors1 trial

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Completed· Novartis logo

Novartis·Phase 2·NCT02187783·106 enrolled

Liposarcoma1 trial

Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

Completed· Novartis logo

Novartis·Phase 1·NCT02343172·74 enrolled

Myelofibrosis1 trial

Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis

Completed· Novartis logo

Novartis·Phase 1·NCT02370706·15 enrolled

13 more indications

Metastatic Melanoma1 trial

Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Completed· Novartis logo

Novartis·Phase 2·NCT03484923·196 enrolled

Impairment1 trial

Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

Completed· Novartis logo

Novartis·Phase 1·NCT02431481·38 enrolled

Hepatocellular Carcinoma1 trial

LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02524119·5 enrolled

Advanced Solid Tumors1 trial

A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1/2·NCT01543698·189 enrolled

Pancreatic Adenocarcinoma1 trial

LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy

Active, not recruiting·GGeorgetown University·Phase 1/2·NCT02985125·44 enrolled

Neuroendocrine Tumors1 trial

A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03070301·21 enrolled

Hepatic Function1 trial

Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011

Completed· Novartis logo

Novartis·Phase 1·NCT02388620·30 enrolled

Cancer of the Head and Neck1 trial

Study of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck

Terminated·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·Phase 1·NCT02429089·21 enrolled

Lymphoma1 trial

A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.

Completed· Novartis logo

Novartis·Phase 1·NCT01237236·156 enrolled

ESS1 trial

Ribociclib (LEE011) Rollover Study for Continued Access

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT02934568·22 enrolled

Neuroblastoma1 trial

Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma

Terminated· Novartis logo

Novartis·Phase 1·NCT01747876·32 enrolled

Teratoma1 trial

A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression

Completed· Novartis logo

Novartis·Phase 2·NCT02300987·10 enrolled

Unspecified1 trial

A Phase I Study of LEE011 in Asian Patients

Completed· Novartis logo

Novartis·Phase 1·NCT01898845·17 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for LEE011. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — LEE011 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for LEE011. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Novartis

LEE011

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Breast Cancer6 trials

Melanoma3 trials

Tumors1 trial

Liposarcoma1 trial

Myelofibrosis1 trial

Metastatic Melanoma1 trial

Impairment1 trial

Hepatocellular Carcinoma1 trial

Advanced Solid Tumors1 trial

Pancreatic Adenocarcinoma1 trial

Neuroendocrine Tumors1 trial

Hepatic Function1 trial

Cancer of the Head and Neck1 trial

Lymphoma1 trial

ESS1 trial

Neuroblastoma1 trial

Teratoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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