Australian oncology-focused company Kazia Therapeutics (ASX:KZA) has announced a collaboration with the Dana-Farber Cancer Institute to investigate the use of its potential new therapy for brain cancer, GDC-0084, in breast cancer that has spread to the brain.
The phase 2 clinical trial will investigate the effects of GDC-0084 in combination with the current standard of care, Roche's PBS-listed Herceptin (trastuzumab), in patients with HER2-positive breast cancer that has metastasised to the brain.
According to Breastcancer.org, approximately 10-15 per cent of women with stage four 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.
Kazia is developing GDC-0084 as a potential treatment for the primary form of brain cancer. The drug targets the signalling pathway implicated in about 90 per cent 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.
Kazia CEO Dr James Garner said: “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 calibre, at a centre held in such high reputation, and we are committed to seeing this important study move forward.”
Explaining the rationale behind the investigation of GDC-0084 as a HER2-positive breast cancer treatment, Kazia’s GDC-0084 clinical program director Dr Jeremy Simpson 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.
“The efficacy of Herceptin 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 Herceptin, in contrast to the primary tumour, 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.”
The Dana-Faber study will run alongside an ongoing phase 2 clinical trial of GDC-0084 in adults with newly-diagnosed glioblastoma. Trial sites are open in the US with further sites to open in Australia in 2019.
Dana-Farber Cancer Institute is based in Boston, Massachusetts, and is a principal teaching affiliate of Harvard Medical School.