Kazia Therapeutics Launches Phase 1b Trial of Paxalisib with Immunotherapy for Advanced Breast Cancer
Key Insights
Kazia Therapeutics (search) has initiated the ABC-Pax trial to evaluate paxalisib combined with immunotherapy in advanced breast cancer (search) patients.
The Phase 1b study will assess the safety and efficacy of paxalisib with pembrolizumab or olaparib in triple-negative breast cancer.
The trial utilizes a novel liquid biopsy platform for real-time monitoring of cancer and immune cell behavior during treatment.
Kazia Therapeutics (search) Limited has announced the launch of the ABC-Pax, a Phase 1b clinical trial evaluating the combination of paxalisib with immunotherapy for patients with advanced breast cancer (search). This open-label, multi-center study marks a novel approach to targeting aggressive and treatment-resistant breast cancer, particularly triple-negative breast cancer (TNBC).
The ABC-Pax trial will enroll 24 patients from leading cancer centers in Queensland, Australia. Participants will receive a combination of paxalisib with either pembrolizumab (Keytruda) or olaparib (Lynparza) for up to 12 months. The primary goal is to assess the safety and efficacy of this novel treatment combination.
The scientific rationale behind the ABC-Pax study stems from preclinical research led by scientists at QIMR Berghofer in collaboration with Kazia Therapeutics (search). This research demonstrated that combining paxalisib with immunotherapy could epigenetically reprogram dormant cancer cells, rendering them visible to the immune system. Furthermore, the combination reinvigorated immune cells, enhancing their ability to target and destroy tumor cells. These findings were presented at the 2024 San Antonio Breast Cancer Symposium.
Professor Sudha Rao from QIMR Berghofer emphasized the urgent need for new treatments for TNBC, stating, "There is no cure for triple negative breast cancer (search) 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 hope is to prolong patient survival through the new combined therapy, which targets the dormant cancer cells that drive the spread and recurrence of the disease and rejuvenates the immune system to more effectively fight the cancer."
In addition to evaluating the drug combination, the ABC-Pax trial will incorporate a non-invasive liquid biopsy digital pathology platform. This platform, developed by Professor Rao's team, allows for real-time monitoring of cancer and immune cell behavior through blood samples. "By regularly analysing blood samples from trial participants using our liquid biopsy digital pathology platform, we can track the effectiveness of the treatment in real time. We believe this approach represents a major advance in precision medicine by offering a faster and more accurate way to monitor patient progress," Professor Rao explained.
Kazia Therapeutics (search) CEO, Dr. John Friend, expressed enthusiasm for the trial, stating, "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 clinical trial is currently open for enrollment at the Royal Brisbane and Women's Hospital, with plans to expand to other sites across Australia.