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.
“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.
- 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
 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
Featured Image: MRI or magnetic resonance image of head and brain scan. Courtesy: ? 2010 – 2018 Fotolia. Used with permission.
Copyright ? 2010 ? 2018 Sunvalley Communication, LLC. All rights reserved. Republication or redistribution of Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco?Zine, Oncozine and The Onco?Zine Brief are registered trademarks and trademarks of Sunvalley Communication around the world.