#Australia #Sydney #TNBC #Kazia Therapeutics #Paxalisib

Kazia Therapeutics Achieves Breakthrough in Tumor Reduction

Kazia Therapeutics Limited (NASDAQ: KZIA), a company dedicated to oncology drug development, made headlines recently with a significant announcement regarding its innovative treatment approach for metastatic triple-negative breast cancer (TNBC). The company reported an 86% reduction in tumor burden in a single-patient expanded-access case treated with a combination regimen that included the investigational drug paxalisib. This remarkable result has vast implications for the future of breast cancer treatment.

Patient Profile and Treatment History

The patient, a woman in her 40s, was first diagnosed with TNBC in April 2023. After undergoing neoadjuvant chemotherapy coupled with immunotherapy, she proceeded to have a bilateral mastectomy six weeks post-treatment, during which no residual cancer was detected. Following this successful intervention, she underwent radiation therapy. However, approximately two years later, she faced a diagnosis of metastatic disease affecting her bones and lungs.

Under the company's expanded-access protocol, the patient was treated with a combination of chemotherapy, immunotherapy, and paxalisib. Just three weeks into this treatment regimen, medical imaging confirmed an 86% overall reduction in tumor size. This outcome is particularly noteworthy as it closely matches the treatment methodologies currently being explored in Kazia's ongoing Phase 1b TNBC study. The study evaluates paxalisib in combination with Keytruda® (pembrolizumab) and chemotherapy, aiming to refine treatment strategies for advanced breast cancer.

Insights from Kazia's CEO

Dr. John Friend, M.D., the CEO of Kazia Therapeutics, expressed optimism about the findings. "Despite being a single-patient case, the speed and scale of tumor regression is profoundly encouraging. It aligns perfectly with our scientific rationale for the use of paxalisib alongside immune checkpoint inhibitors," he stated. Dr. Friend emphasized the significance of this case in reinforcing the company’s commitment to their ongoing trials and the promising potential of paxalisib in disrupting tumor cell clusters, as indicated by recent research.

The Ongoing Phase 1b TNBC Trial

Kazia is currently running a multi-centered Phase 1b study in Australia that focuses on the combined use of paxalisib, Keytruda®, and chemotherapy tailored for advanced breast cancer including TNBC. This trial is meticulously designed to evaluate safety, preliminary anti-tumor activity, and various biomarkers relating to circulating tumor cells. Understanding these dynamics is essential for optimizing immunotherapy responses among patients.

About Paxalisib and Future Directions

Paxalisib is a cutting-edge PI3K/Akt/mTOR pathway inhibitor. Since its licensing from Genentech in late 2016, it has been at the forefront of numerous clinical trials targeting various cancer forms, including glioblastoma and advanced breast cancer. Recent discussions are already underway to initiate pivotal studies aimed at achieving standard approval in glioblastoma, alongside encouraging interim results in trials addressing other malignancies.

Kazia has received several recognitions from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for multiple indications. The company is also developing EVT801, a small molecule inhibitor targeting VEGFR3, which has shown promising preclinical results across a wide spectrum of tumors, especially in collaboration with immuno-oncology treatments.

Conclusion

Kazia Therapeutics is making significant strides in the realm of oncology, and the recent impressive data from the expanded access case not only underscores the potential of paxalisib in the fight against metastatic TNBC but also reaffirms the company’s commitment to improving outcomes for patients battling breast cancer. As they continue their research and trials, the oncology community is keenly watching for further developments from Kazia.