Kazia Therapeutics Begins Trial of Paxalisib and Immunotherapy for Advanced Breast Cancer

Friday, January 31, 2025

Kazia Therapeutics has received regulatory approval to initiate a clinical trial evaluating a combination of paxalisib and immunotherapy for patients with advanced breast cancer.

Breast cancer is one of the most common cancers worldwide, affecting millions of women each year. It occurs when abnormal cells in the breast grow uncontrollably, forming a tumour that may spread to other parts of the body.

This new treatment combination aims to improve outcomes for patients with aggressive breast cancer. By targeting dormant cancer cells responsible for disease spread and recurrence, the approach seeks to extend survival and enhance quality of life.

This study explores a novel treatment approach for a highly aggressive and treatment-resistant cancer type.

The ABC-Pax (Advanced Breast Cancer – Paxalisib) trial is the first known study to assess the safety and efficacy of paxalisib when used alongside either pembrolizumab (KEYTRUDA®) or olaparib (LYNPARZA®) in women with triple-negative breast cancer. 

This phase 1b, open-label, multi-centre study will enrol 24 patients from leading cancer centres in Queensland, Australia. Participants will receive the combination therapy for up to 12 months.

The trial builds on research led by QIMR Berghofer scientists in collaboration with Kazia Therapeutics. Preclinical studies demonstrated that combining paxalisib with immunotherapy activates a specific molecular process that makes dormant cancer cells detectable to the immune system. 

This approach also revitalises immune cells to enhance their response against tumours. Findings from these studies were presented at the San Antonio Breast Cancer Symposium on 12 December 2024, highlighting the potential benefits of combining paxalisib with pembrolizumab or olaparib in cases of immunotherapy-resistant triple-negative breast cancer.
 
The study is now open for patient enrolment at the Royal Brisbane and Women's Hospital, with plans for further expansion in Australia.

The ABC-Pax trial will also incorporate a non-invasive liquid biopsy digital pathology platform developed by researchers at QIMR Berghofer. 

This technology allows real-time monitoring of cancer and immune cell activity through blood samples. 

By regularly analysing these samples, researchers can assess treatment effectiveness more accurately, supporting advancements in precision medicine.

 

Source: kaziatherapeutics.com