Back/Kazia Therapeutics' Paxalisib Shows Promise in Treating HER2-Positive Metastatic Breast Cancer
pharma·September 13, 2025·kzia

Kazia Therapeutics' Paxalisib Shows Promise in Treating HER2-Positive Metastatic Breast Cancer

ED
Editorial
Cashu Finance·2 min read
TL;DR
  • Kazia Therapeutics' paxalisib shows significant reduction in circulating tumor cells for Stage IV HER2-positive metastatic breast cancer.
  • The company is also conducting a Phase 1b trial for paxalisib in triple-negative breast cancer with promising initial results.
  • Kazia plans to present detailed datasets on metastatic signatures at a global oncology meeting in 2025.

Kazia Therapeutics Advances Cancer Treatment with Promising Paxalisib Findings

Kazia Therapeutics Limited, an oncology-focused drug development company, announces significant advancements in the treatment of Stage IV HER2-positive metastatic breast cancer (mBC) through its investigational drug, paxalisib. Recent research led by Professor Sudha Rao at QIMR Berghofer investigates the effects of paxalisib, a PI3K–mTOR inhibitor, on blood samples from patients suffering from this aggressive cancer subtype. The study presents compelling evidence that paxalisib monotherapy leads to a statistically significant reduction in single circulating tumor cells (CTCs) and achieves a complete 100% disruption of CTC clusters. These findings are crucial as CTCs serve as important biomarkers for disease progression and metastatic activity, particularly in HER2-positive breast cancer, which comprises 15-20% of breast cancer cases and is notorious for its resistance to traditional therapies.

The implications of the study are particularly noteworthy given the challenges faced by patients with HER2-positive mBC, who often experience recurrence despite the availability of HER2-targeted treatments. Dr. John Friend, CEO of Kazia Therapeutics, underscores the promising potential of paxalisib, suggesting that its efficacy may extend beyond previously established applications in triple-negative breast cancer (TNBC). The precision medicine approach utilized in the research highlights the importance of biomarkers in monitoring metastatic burden and tailoring treatment strategies. This innovative perspective positions paxalisib as a viable therapeutic option for a patient population that currently faces limited treatment avenues.

Kazia Therapeutics is not only focusing on HER2-positive mBC; the company is concurrently conducting a Phase 1b trial for paxalisib in Stage IV triple-negative breast cancer. Initial data from this trial have also shown significant reductions in CTCs and clusters, reinforcing the drug's potential across different breast cancer subtypes. Looking ahead, Kazia plans to showcase detailed datasets on metastatic signatures at a global oncology meeting in 2025, emphasizing their commitment to addressing the critical unmet medical needs in the landscape of advanced breast cancer treatments.

In addition to their promising findings, Kazia Therapeutics is strategically positioning itself as a leader in the oncology space by exploring the broader implications of their research. The focus on precision medicine not only enhances the understanding of treatment efficacy but also aids in personalized patient care. With ongoing trials and a commitment to innovation, Kazia is poised to make significant contributions to the field of oncology, potentially reshaping the treatment landscape for HER2-positive and triple-negative breast cancer patients.