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Brigatinib*

Anaplastic Lymphoma Kinase Inhibitor ALK+ Non-Small Cell Lung Cancer

Overview1,2

- Brigatinib is a small-molecule inhibitor designed to target anaplastic lymphoma kinase (ALK) rearrangements in non-small cell lung cancer

- Brigatinib was designed using a structure-based platform to be a potent, selective inhibitor of ALK

MOA3

- Brigatinib is a tyrosine kinase inhibitor, acting on numerous kinases including ALK, ROS1, IGF-IR, FLT-3 and EGFR deletion and point mutations
(in vitro at clinically achievable concentrations)

- Brigatinib inhibited in vitro proliferation of cell lines expressing EML-4-ALK and NPM-ALK fusion proteins

- Brigatinib inhibited EML-4-ALK-positive NSCLC xenograft growth in a dose-dependent manner in mice

Clinical Trials
Study Name

An Observational Parallel Group Phase 4 Study to Determine Progression-Free Survival and Evaluate Patient Experience for Patients With Metastatic ALK+ Non-Small Cell Lung Cancer (NSCLC) Treated With ALK Inhibitors

CT.GOV ID

NCT03546894

Phase

Phase 4

Status

Recruiting
Study Name

Brigatinib-3001: A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

CT.GOV ID

NCTO3596866

Phase

Phase 3

Status

Recruiting
Study Name

Brigatinib-2001: A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

CT.GOV ID

NCTO3410108

Phase

Phase 2

Status

Active, not recruiting
Study Name

Brigatinib-2002: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

CT.GOV ID

NCT03535740

Phase

Phase 2

Status

Active, not recruiting

References

1. Zhang S, et al. AACR 2015 [poster 781].

2. Zhang S, et al. Clin Cancer Res. 2016;22:5527-5538.

3. ALUNBRIG® PI, 2020.

Disclaimers

Efficacy and safety of these products, for the uses identified within, are currently under investigation. Regulatory approval of any of these products or uses is dependent on the completion of the study programs and review by regulatory authorities. The clinical trial information is available at www.clinicaltrials.gov *Marketed products have received approval in one or more jurisdictions.

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