Trial of Paxalisib With Immunotherapy in Advanced Breast Cancer Begins
This approach aims to improve treatment for patients with this highly aggressive and treatment-resistant type of breast cancer.
Breast cancer cells: © LASZLO- stock.adobe.com
A trial evaluating the combination of paxalisib with immunotherapy for the treatment of patients with advanced breast cancer has been launched, according to a press release from Kazia Therapeutics Limited.1
This trial, named the ABC-Pax study, represents a novel approach aimed at targeting aggressive triple-negative breast cancer. The study is the first to assess paxalisib, an investigational drug, in combination with either pembrolizumab (Keytruda), a checkpoint inhibitor, or olaparib (Lynparza), a PARP inhibitor.
ABC-Pax is a multicenter, open-label, phase 1b study that will enroll 24 patients from cancer centers in Queensland, Australia. The patients will receive the combination of paxalisib with immunotherapy for up to 12 months. The goal of the study is to evaluate the safety and efficacy of the treatment.
The combination of paxalisib and immunotherapy builds on promising preclinical research where the combination showed the potential to reprogram dormant cancer cells, making them visible to the immune system and stimulating immune cells to more effectively attack tumor cells.2
These findings shared during the 2024 San Antonio Breast Cancer Symposium, showing the potential synergies between paxalisib and both pembrolizumab and olaparib. This clinical trial is open for enrollment at the Royal Brisbane and Women's Hospital, with plans to expand to other sites across Australia.1
In addition to evaluating this innovative drug combination, the ABC-Pax study will incorporate a non-invasive liquid biopsy digital pathology platform that allows for real-time monitoring of cancer and immune cell behavior through blood samples.
"By regularly analyzing 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," Sudha Rao, professor at QIMR Berghofer, said in a press release.
"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," added John Friend, MD, chief executive officer of Kazia Therapeutics, in the press release.
REFERENCES:
Kazia Therapeutics announces the launch of a groundbreaking trial with paxalisib in combination with immunotherapy in women with advanced breast cancer. News release. Kazia Therapeutics Limited. January 30, 2025. Accessed February 6, 2025. https://tinyurl.com/yc6mk8re
Kazia Therapeutics to present data highlighting synergistic activity between paxalisib and immunotherapy in immunotherapy-resistant triple negative breast cancer odel at the San Antonio Breast Cancer Symposium. News release. Kazia Therapeutics Limited. December 11, 2024. Accessed February 6, 2025. https://tinyurl.com/mtdurnmu
