News & Trends - Biotechnology
Aussie biotech leads world-first combination trial in aggressive breast cancer

A world-first clinical trial is set to explore a promising new combination therapy for triple-negative breast cancer, one of the most aggressive and treatment-resistant forms of the disease.
This Australian trial will assess the efficacy of Kazia Therapeutics’ Paxalisib, a dual PI3K/mTOR inhibitor initially developed by Genentech for brain cancer, due to its unique ability to cross the blood-brain barrier. This is particularly significant as the brain is a common site for metastases in triple-negative breast cancer.
Professor Sudha Rao of QIMR Berghofer highlighted the urgent need for new treatment options, saying “There is no cure for advanced triple-negative breast cancer, and the life expectancy for these women is tragically short. We want to identify treatments to extend the duration and quality of life of these patients.”
The ABC-Pax trial is the first to evaluate Paxalisib in combination with AstraZeneca’s Lynparza (olaparib) or MSD’s Keytruda (pembrolizumab) in women with metastatic triple-negative or BRCA mutation-associated breast cancer.
Professor Rao explained the approach behind the study, saying “Our pre-clinical research has shown for the first time that Paxalisib activates dormant cancer cells, making them visible to the immune system and helping immunotherapy to effectively function.
“This could be a game changer because we know immunotherapy is only successful in a handful of patients with metastatic triple-negative breast cancer. Our pre-clinical findings have given us real hope that Paxalisib could ensure immunotherapy is effective for more patients.”
The multi-centre, open-label phase 1b trial will recruit patients from leading cancer treatment centres in Queensland, including the Royal Brisbane and Women’s Hospital, with participants receiving the combination therapy for up to 12 months.
Dr John Friend, CEO of Sydney-based Kazia Therapeutics, said “The novelty of the science that Professor Rao has proposed with this dual combination of Paxalisib and immunotherapy could advance the treatment of women with aggressive breast cancer, and we are excited to support this unique clinical study.”
The ABC-Pax trial will also incorporate a pioneering, non-invasive liquid biopsy digital pathology platform developed by Professor Rao and her team. This innovative technology aims to monitor cancer and immune cell behaviour in real-time, allowing researchers to track treatment efficacy.
“By regularly analysing blood samples from trial participants using our liquid biopsy digital pathology platform, we will be able to track the effectiveness of the treatment. This approach represents a major advance in precision medicine by offering a faster and more accurate way to monitor patient progress,” Professor Rao said.
“We hope this liquid biopsy test could one day become a standard tool for detecting the spread of cancer early, when treatment could be most effective.”
Professor Rao acknowledged the crucial support that has helped advance this research, including contributions from the Daniela Dwyer Foundation, Breast Friends, and the family and friends of Canberra mother-of-two Melanie Swan.
“This support is vital to help us advance our work. In particular, my team and I are inspired every day by two very special women who championed our research – my friend Melanie Swan who passed away from metastatic breast cancer when she was 43 years old, and Daniela Dwyer who was 34 years old when she passed away from brain cancer.
“Daniela’s blood samples, which she provided after receiving Paxalisib on compassionate grounds, have been pivotal to helping us advance our research,” Professor Rao said.
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