Back/Kazia Therapeutics Reports 86% Tumor Reduction in Advanced Triple-Negative Breast Cancer Treatment
pharma·October 3, 2025·kzia

Kazia Therapeutics Reports 86% Tumor Reduction in Advanced Triple-Negative Breast Cancer Treatment

ED
Editorial
Cashu Finance·2 min read
TL;DR
  • Kazia Therapeutics reports an 86% tumor reduction in a patient with advanced triple-negative breast cancer using paxalisib.
  • The case aligns with Kazia's ongoing Phase 1b trial assessing paxalisib's safety and efficacy in TNBC treatment.
  • Kazia remains committed to innovative oncology solutions, targeting unmet needs in aggressive cancers like triple-negative breast cancer.

Kazia Therapeutics Reports Promising Results in Triple-Negative Breast Cancer Treatment

Kazia Therapeutics Limited, an oncology-focused drug development company based in Sydney, Australia, announces encouraging results from a single-patient expanded access case involving a 40-year-old woman with triple-negative breast cancer (TNBC). Initially diagnosed in April 2023, the patient underwent neoadjuvant chemotherapy and immunotherapy, leading to a bilateral mastectomy six weeks later, which indicated no residual cancer. However, two years post-surgery, she developed metastatic disease affecting her bones and lungs. Under a single-patient expanded-access protocol, Kazia provided a regimen that combined immunotherapy, chemotherapy, and its investigational drug, paxalisib.

After only three weeks of treatment, imaging results reveal an impressive 86% reduction in the overall tumor burden, showcasing the potential efficacy of paxalisib in combating advanced TNBC. This case is significant as it aligns with the patient demographics and treatment methodologies being explored in Kazia's ongoing Phase 1b study of TNBC. This trial assesses the safety and preliminary anti-tumor activity of paxalisib in conjunction with Keytruda® (pembrolizumab) and chemotherapy. Dr. John Friend, CEO of Kazia Therapeutics, expresses optimism regarding the substantial tumor regression observed in this case, reiterating the company’s commitment to advancing its Phase 1b trial for patients with advanced breast cancer.

Kazia's lead program, paxalisib, is an investigational inhibitor targeting the PI3K/Akt/mTOR pathway, a critical signaling pathway involved in cancer cell growth and survival. The ongoing Phase 1b trial not only evaluates the drug's safety profile but also seeks to identify translational biomarkers related to circulating tumor cell dynamics. The promising response seen in this single case could pave the way for broader applications of paxalisib in treating TNBC and possibly other malignancies, reinforcing Kazia's position in the competitive oncology landscape.

Beyond this promising development, Kazia Therapeutics remains focused on advancing its research and expanding its clinical programs. The company is dedicated to addressing significant unmet needs in oncology, particularly for aggressive cancer types like TNBC. Kazia's innovative approach in utilizing paxalisib highlights its commitment to finding effective treatments that could improve outcomes for patients battling challenging cancers.