Core Insights - Kazia Therapeutics has announced preliminary results from its Phase 1b trial involving Paxalisib, pembrolizumab, and standard chemotherapy, showing promising outcomes in a patient with metastatic triple-negative breast cancer [1][5][6] Patient Profile - The trial's first patient is a 61-year-old female diagnosed with metastatic triple-negative breast cancer, specifically localized to the left upper lobe of the lung [3] Clinical Significance of Patient Data - Circulating tumor cell (CTC) clusters are critical in metastasis and are associated with poor prognosis; they can resist apoptosis and evade immune detection [4] - The combination treatment of Paxalisib and immunotherapy resulted in a rapid reduction of both CTC numbers and clusters, which is not typically observed with chemotherapy or immunotherapy alone [5][6] Mechanistic Insights - The early data aligns with preclinical findings that suggest Paxalisib disrupts both single CTCs and multicellular clusters, indicating a mechanistic synergy [2][5] Next Steps - The company plans to explore the relationship between CTC kinetics and radiographic responses, continue patient enrollment, and conduct a comprehensive analysis of the immune microenvironment and CTC kinetics [7] - The investigational regimen includes Paxalisib, pembrolizumab, and chemotherapy, with results showing over 50% reduction in total CTC count and a notable decrease in CTC clusters [7] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being Paxalisib, which targets the PI3K/Akt/mTOR pathway for various cancers [9]