Kazia Therapeutics’ paxalisib combination shows tumor reduction

Kazia Therapeutics (KZIA) reported a substantial reduction in tumor burden from a single-patient expanded access case in triple-negative breast cancer – TNBC – treated with a combination regimen that included the company’s investigational pan-PI3K/mTOR inhibitor, paxalisib. After three weeks of combination immunotherapy/chemotherapy plus paxalisib, imaging performed at the treating institution showed an 86% reduction in overall tumor burden. The patient is a 40+ year old female initially diagnosed with TNBC in April 2023. She received neoadjuvant chemotherapy and immunotherapy, followed by bilateral mastectomy six weeks post-treatment with no residual cancer detected, followed by radiation therapy. Approximately two years later, the patient was diagnosed with metastatic disease to bone and lungs. She was then treated under a single-patient expanded-access protocol with an immunotherapy/chemotherapy regimen plus paxalisib. After three weeks of therapy, imaging demonstrated an 86% overall tumor reduction. CEO John Friend said, “This experience reinforces our commitment to our ongoing, company sponsored Phase 1b trial in advanced breast cancer, and it echoes the recent ex-vivo findings showing disruption of circulating tumor cell clusters with paxalisib.”