BYL719

Phase 2Small molecule

Novartis

BYL719 is one of 244 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

243

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

Pancreatic CancerActive, not recruiting

Gastric CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

Squamous Cell CarcinomaActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 1

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

MelanomaPhase 1

Active, not recruiting

Pancreatic CancerPhase 1

Active, not recruiting

Gastric CancerPhase 1

Active, not recruiting

Multiple MyelomaPhase 1

Active, not recruiting

Squamous Cell CarcinomaPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BYL719

Novartis

Phase 2

8 2

Avastin

Voltaren

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Zinecard

CChildren's Oncology Group

Preclinical

2 6

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 7

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 8

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 9

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 10

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1/2Active, not recruiting

Breast Cancer

NCT01872260

Clinical

Trials by Indication[1]

Breast Cancer8 trials

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

Active, not recruiting· Novartis logo

Novartis·Phase 1/2·NCT01872260·255 enrolled

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02167854·23 enrolled

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02051751·19 enrolled

Show 5 more trials

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01300962·47 enrolled

Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer

Completed·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT02506556·38 enrolled

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

Completed· Novartis logo

Novartis·Phase 1·NCT02088684·70 enrolled

BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT01870505·52 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

Esophageal Squamous Cell Carcinoma2 trials

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

Completed·SSeoul National University Hospital·Phase 2·NCT03292250·180 enrolled

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Completed· Novartis logo

Novartis·Phase 1·NCT01822613·48 enrolled

Solid Tumors2 trials

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01928459·62 enrolled

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

Terminated· Novartis logo

Novartis·Phase 1/2·NCT01708161·47 enrolled

Squamous Cell Carcinoma2 trials

Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Withdrawn·—·Phase 1/2·NCT02298595

An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy.

Unknown status·YYonsei University·Phase 2·NCT02145312·43 enrolled

Advanced Solid Malignancies2 trials

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Completed· Novartis logo

Novartis·Phase 1·NCT01387321·33 enrolled

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Completed· Novartis logo

Novartis·Phase 1·NCT01219699·221 enrolled

11 more indications

Gastric Cancer1 trial

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT01613950·18 enrolled

Melanoma1 trial

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

Completed·—·Phase 1·NCT02273219·30 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT02276027·66 enrolled

Intensity-modulated Radiation Therapy1 trial

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02282371·16 enrolled

Metastatic Colorectal Cancer1 trial

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01719380·156 enrolled

Head and Neck Cancer1 trial

Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer

Completed·UUniversity Health Network, Toronto·Phase 1·NCT02537223·9 enrolled

Pancreatic Cancer1 trial

BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02155088·15 enrolled

Multiple Myeloma1 trial

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

Completed· Novartis logo

Novartis·Phase 1·NCT02144038·20 enrolled

Selected Advanced Solid Tumors1 trial

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Completed·UUnknown Sponsor·Phase 1·NCT01449058·139 enrolled

Head and Neck Squamous Cell Cancer1 trial

A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·N/A·NCT03138070·15 enrolled

Rectal Cancer1 trial

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

Terminated·Hhoward safran·Phase 1·NCT02550743·7 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for BYL719. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BYL719 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BYL719. 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

BYL719

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Breast Cancer8 trials

Esophageal Squamous Cell Carcinoma2 trials

Solid Tumors2 trials

Squamous Cell Carcinoma2 trials

Advanced Solid Malignancies2 trials

Gastric Cancer1 trial

Melanoma1 trial

Non-Small Cell Lung Cancer1 trial

Intensity-modulated Radiation Therapy1 trial

Metastatic Colorectal Cancer1 trial

Head and Neck Cancer1 trial

Pancreatic Cancer1 trial

Multiple Myeloma1 trial

Selected Advanced Solid Tumors1 trial

Head and Neck Squamous Cell Cancer1 trial

Rectal Cancer1 trial

References

Drug Info

Quick Facts

Related News