Kazia Therapeutics Reports Early Efficacy Data from First Triple-Negative Breast Cancer Patient Receiving Paxalisib Combination Regimen achieving >50% Reduction in Circulating Tumor Cells in Phase 1b

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Jul 09, 2025
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  • The first patient in Kazia Therapeutics' (NASDAQ: KZIA) Phase 1b trial showed a >50% reduction in circulating tumor cells (CTCs).
  • The combination therapy of Paxalisib and pembrolizumab reduced both single CTCs and clusters, crucial for metastasis.
  • Significant early findings align with preclinical research, indicating promising anti-metastatic potential.

Kazia Therapeutics (KZIA, Financial) has released promising early results from its Phase 1b trial, combining Paxalisib with pembrolizumab and standard chemotherapy. The study is focused on patients with metastatic triple-negative breast cancer. The first patient, a 61-year-old woman, exhibited a greater than 50% reduction in circulating tumor cells (CTCs) after just 21 days of treatment.

The investigational regimen led to a remarkable reduction in both single CTCs and CTC clusters, the latter known to be 20 to 100 times more efficient at causing metastasis than individual CTCs. Additionally, the treatment reduced the mesenchymal phenotype of the remaining CTCs, a trait associated with aggressive cancer cells.

These initial trial results are consistent with preclinical findings published in Molecular Cancer Therapeutics. The ongoing trial aims to further assess the safety, tolerability, and pharmacodynamics of the treatment as more patients are enrolled.

Dr. John Friend, CEO of Kazia Therapeutics, emphasized the significance of these findings, stating that the reduction in CTCs and clusters is promising for early intervention in systemic disease progression. The trial will continue to explore the relationship between CTC kinetics and radiographic responses, as well as long-term outcomes such as progression-free survival.

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