BYL719

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

7 competitors in Head and Neck Squamous Cell Cancer

#DrugCompanyPhaseTrials

1

Keytruda

Merck & Co.

Phase 2

52

Taxol

Teva

Phase 2

23

Cabometyx

Bristol-Myers Squibb

Phase 2

24

Nexavar

Bayer

Phase 2

15

Trodelvy

Gilead

Phase 2

16

Erbitux

IImclone

Phase 2

67

Paraplatin

AAvyxa

Phase 2

28

BYL719

Novartis

Preclinical

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Breast Cancer8 trials

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

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

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

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

Terminated·Novartis·Phase 1·NCT02734615·199 enrolled

Show 5 more trials

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·Phase 1·NCT02051751·19 enrolled

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

Completed·Novartis·Phase 1·NCT02088684·70 enrolled

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

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

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

Active, not recruiting·Novartis·Preclinical·NCT01872260·259 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·Phase 1·NCT01822613·48 enrolled

Advanced Solid Malignancies2 trials

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Completed·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·Phase 1·NCT01219699·221 enrolled

Solid Tumors2 trials

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

Terminated·Novartis·Phase 1/2·NCT01708161·47 enrolled

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Completed·Novartis·Phase 1·NCT01928459·62 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

11 more indications

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

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

Metastatic Colorectal Cancer1 trial

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

Completed·Pfizer·Phase 2·NCT01719380·156 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

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

Gastric Cancer1 trial

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

Completed·Novartis·Phase 1·NCT01613950·18 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

Multiple Myeloma1 trial

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

Completed·Novartis·Phase 1·NCT02144038·20 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·Phase 2·NCT02276027·66 enrolled

Details

Drug Info

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