#Australia #Sydney #Kazia Therapeutics #Paxalisib #Triple-Negative Breast Cancer

Kazia Therapeutics Reports Significant Reduction in Tumor Cells from Clinical Trial

Kazia Therapeutics, an oncology-focused drug development company, has made headlines with the preliminary results from its Phase 1b clinical trial. The trial investigates a combination treatment regimen involving Paxalisib, pembrolizumab (better known as Keytruda), and standard chemotherapy. These results come after the completion of the first treatment cycle for the initial patient, revealing a striking response in managing metastatic triple-negative breast cancer (TNBC).

Patient Profile and Initial Results

The first patient to receive this combination therapy is a 61-year-old woman suffering from metastatic TNBC, specifically with tumors localized to the left upper lobe of her lung. After just 21 days of treatment (one cycle), this patient exhibited a greater than 50% reduction in circulating tumor cells (CTCs), alongside a noteworthy decrease in CTC clusters. These clusters of tumor cells are typically associated with a more aggressive cancer and often complicate treatment outcomes.

These early findings resonate closely with earlier preclinical research published in Molecular Cancer Therapeutics, which indicated that when Paxalisib was used with immunotherapy, it substantially hindered both isolated CTCs and clustered arrangements in laboratory settings.

Noteworthy Highlights:

• - Significant Reduction: Over 50% decline in total CTC count noted at day 21
• - CTC Clusters: Similar reduction observed in the clusters, indicating a potential reduction in metastatic risks
• - Mesenchymal Phenotype: A drop in the aggressive mesenchymal phenotype of remaining CTCs, raising hopes for decreased metastatic seeding of cancer cells

The Clinical Relevance of These Data

CTC clusters have long been acknowledged as critical players in the metastasis of cancers, often linked to poor prognoses due to their abilities to evade immune detection and seed new tumors efficiently. Conventional chemotherapy has, in certain scenarios, shown to temporarily increase the counts of CTCs and clusters during initial treatment cycles. In stark contrast, immunotherapy has typically yielded inconsistent outcomes regarding CTC reduction. This initial combined therapy of Paxalisib and immunotherapy has demonstrated rapid and significant declines in CTC counts and clusters, an outcome that has not been previously observed with either treatment alone after a mere 21 days.

CEO Dr. John Friend expressed enthusiasm over these promising results, stating, "The impressive reductions in markers of tumor cell dissemination within just 21 days provide us strong justification for optimism as this clinical trial progresses." He also highlighted the significance of CTC clusters, noting their high efficiency at spreading cancer metastases.

Future Directions

Looking ahead, Kazia Therapeutics plans to:

• - Delve deeper into how CTC behavior correlates with radiographic responses amid continued enrollment in the Phase 1b study to expand their cohort size and test safety parameters.
• - Conduct thorough analyses to understand the immune microenvironment and CTC dynamics across patients through serial monitoring.
• - Implement long-term follow-ups that shall encompass imaging, progression-free survival metrics, and a detailed correlation study with molecular markers.

About Kazia Therapeutics
Kazia Therapeutics is headquartered in Sydney, Australia, and specializes in comprehensive drug development targeting various cancer types. Their lead program, Paxalisib, is recognized for its ability to penetrate brain tissues and disrupt specific cancer-promoting pathways. This investigational drug has completed several trials and has garnered significant FDA designations aimed at expediting its approval processes.

This recent clinical success not only highlights the potential of innovative therapies in advancing TNBC treatments but also underscores Kazia's commitment to improving patient outcomes through diligent research and development efforts.