Tucatinib (ONT-380)

Target: HER2 | Disease State: Breast Cancer

Introduction / Brief Description

Tucatinib is an orally active, reversible, and selective small molecule HER2 inhibitor invented by Array and licensed to Cascadian Therapeutics (previously named Oncothyreon) for development, manufacturing, and commercialization. In March 2018, Seattle Genetics acquired Cascadian Therapeutics. The licensing agreement between Array and Cascadian remains in effect.

Tucatinib is advancing in a registration trial and multiple Phase 1 and 2 trials in patients with breast or colorectal cancers.

Breast Cancer

Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed. While significant progress has been made in the treatment of breast cancer, globally around 520 thousand women die from the disease annually. In 2014, it is projected that over 230 thousand women will be diagnosed with breast cancer and approximately 40 thousand will die from the disease in the United States. Approximately 20% of patients with breast cancer test positive for HER2, which promotes the growth of cancer cells. Brain metastasis is observed in 10% of metastatic breast cancer patients, with an even higher likelihood in HER2+ disease (15%-29%). Many of the breast cancer therapies (like targeted antibodies) fail to penetrate the blood–brain barrier, hence allowing for tumor recurrence in the central nervous system. Therefore, an effective therapy for patients with HER2+ patients with brain metastases would address a significant unmet need in the treatment of breast cancer.

Clinical Trials

To learn more about tucatinib clinical trials, click here.

Publications and Presentations

ARRY-380

06/01/2015

American Society of Clinical Oncology Meeting

ONT-380 in the Treatment of HER2+ Breast Cancer Central Nervous System (CNS) Metastases (Mets)

C. Ferrario, et al.

ARRY-380

10/17/2012

American Association of Pharmaceutical Scientists, Annual Meeting and Exposition

Amorphous Dispersion Development of ARRY-380, an ErbB2 Selective Inhibitor

C. Lindemann, et al.

ARRY-380

10/17/2012

American Association of Pharmaceutical Scientists, Annual Meeting and Exposition

Solid-State Characterization of Seven Isomorphic Solvates of ARRY-380

C. Lindemann, et al.


To view all publications, click here.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.