MRI or magnetic resonance image of head and brain scan. Close up view, toned image

Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School, will collaborate with oncology-focused biotech company Kazia Therapeutics, an innovative oncology-focused biotechnology company, based in Sydney, Australia, to investigate the use of the company’s potential new therapy for brain cancer, GDC-0084, in breast cancer that has spread to the brain.

The Phase II clinical study is designed to investigate the effects of GDC-0084 in combination with the current standard of care, trastuzumab (Herceptin?; Genentech/Roche) in patients with HER2-positive breast cancer that has metastasized to the brain.

About 10-15% of women with stage IV breast cancer develop brain metastases.

The study is estimated to recruit between 22 and 49 patients, and will take up to three years to complete.

GDC-0084 is being developed as a potential treatment for glioblastoma multiforme (GBM), the primary form of brain cancer. The investigational drug targets the signaling pathway implicated in about 90% of glioblastoma cases, and is differentiated from other brain cancer treatments by its ability to cross the so called ?blood-brain? barrier that prevents many drugs from fully impacting the brain.

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“We strongly believe in the potential for GDC-0084 to bring benefit to patients with other forms of brain cancer beyond glioblastoma, and it is exciting to be working with the team at Dana-Farber to explore its potential use in this very challenging disease. It is extremely rewarding to be able to work with specialist researchers of this caliber, at a center held in such high reputation, and we are committed to seeing this important study move forward,” James Garner, MD, Chief Executive Officer at Kazia Therapeutics said.

“HER2 is a protein that promotes the growth of cancer cells. Approximately 20-30% of early-stage breast cancers show amplification of a gene associated with HER2, and these patients are generally treated with Herceptin, an anti-HER2 monoclonal antibody,” explained Jeremy Simpson, MD, Kazia?s Clinical Program Director for GDC-0084.

?The efficacy of [trastuzumab] is well established. However, breast cancer can nevertheless spread to other parts of the body, a process described as metastasis, and in about a third of such cases the brain is the site to which it spreads. Such brain metastases are often highly resistant to [trastuzumab], in contrast to the primary tumor, and there remains a substantial need for new therapies in this patient population. Recent research suggests that the PI3K pathway may represent an important part of this resistance mechanism, and so there is a sound rationale to explore GDC-0084, a brain-penetrant PI3K inhibitor, as a potential treatment for patients with breast cancer that has metastasized to the brain,” Simpson added.

The Dana-Faber study will run alongside an ongoing phase II clinical trial of GDC-0084 in adults with newly-diagnosed glioblastoma. Trial sites are open in the United States, with further sites to open in Australia in 2019.

Analysts forecast that the HER2-positive treatment market is estimated to reach $12.7 billion by 2023[1].

Clinical trials

  • Safety, Pharmacokinetics and Efficacy of GDC-0084 in Newly-diagnosed Glioblastoma Multiforme – NCT03522298
  • Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas – NCT03696355

[1] September 2014, Her-2 Positive Breast Cancer Global Drug Forecast and Market Analysis to 2023, Global Data PharmaPoint, GDHC86PIDR

Last Editorial Review: October 21, 2018

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