Kazia Therapeutics reports early data from breast cancer trial patient

Kazia Therapeutics (NASDAQ: KZIA) reported preliminary results from the first patient in its Phase 1b trial testing a combination of Paxalisib, pembrolizumab, and chemotherapy for metastatic triple-negative breast cancer.

The 61-year-old female patient showed a greater than 50% reduction in circulating tumor cells (CTCs) after completing one 21-day treatment cycle, according to the company's press release. The patient's cancer had metastasized to the left upper lobe of the lung.

The trial is evaluating Paxalisib, an investigational PI3K/mTOR pathway inhibitor, in combination with pembrolizumab and standard chemotherapy. The patient also demonstrated a reduction in CTC clusters, which are associated with metastatic potential, and a decrease in the mesenchymal phenotype of remaining CTCs.

"The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial," said Dr. John Friend, CEO of Kazia Therapeutics.

The company noted that standard chemotherapy has been shown in some studies to temporarily increase CTC counts within the first cycle, while immunotherapy alone typically shows delayed effects on CTCs. The combination regimen achieved rapid reduction in both CTC numbers and clusters after 21 days of treatment.

Kazia plans to continue enrollment in the Phase 1b study to assess safety, tolerability, and pharmacodynamics across a larger patient cohort. The company will monitor the relationship between CTC kinetics and radiographic responses, along with longer-term follow-up including imaging and progression-free survival assessments.

The Sydney-based oncology company licensed Paxalisib from Genentech in 2016. The drug has received Orphan Drug Designation and Fast Track Designation from the FDA for various cancer indications, including glioblastoma and solid tumor brain metastases.

You May Also Be Interested In

• FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
• Alzamend Neuro (ALZN) files for 98.4M share offering by selling stockholders
• Lazard Global Total Return fund declares $0.1534 monthly distribution