Kazia Therapeutics(US:KZIA) Prnewswire·2026-01-27 13:00Core Insights - Kazia Therapeutics provided a clinical update on its Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy for late-stage metastatic triple-negative breast cancer (TNBC) [1] Clinical Highlights - The Phase 1b trial is a multi-center, open-label, randomized study initiated in June 2025, focusing on the safety, tolerability, and preliminary clinical activity of paxalisib in advanced breast cancer patients [4] - Three patients with metastatic TNBC have shown meaningful clinical responses, including two partial responses and one confirmed complete metabolic response [2][9] Patient Responses - Patient 1, a 61-year-old female, achieved a partial response after nine cycles of treatment with paxalisib, pembrolizumab, and chemotherapy [5] - Patient 2, a 47-year-old female, demonstrated a partial response with complete resolution of a target lung lesion after three treatment cycles [6] - Patient 3, a 44-year-old female, achieved a confirmed complete metabolic response after re-treatment with paxalisib and pembrolizumab [7] Safety and Tolerability - Paxalisib has been generally well tolerated, with approximately 75% of adverse events assessed as unlikely or unrelated to the drug [8] - Most adverse events were mild to moderate, with only one case of Grade 1 hyperglycemia reported [8] Future Plans - Kazia plans to activate two additional clinical sites by April 2026 and aims to enroll twelve TNBC patients by the end of 2026, with topline data expected in early 2027 [9] - The company is also exploring paxalisib in other breast cancer populations, including earlier-stage TNBC and hormone receptor-positive, HER2-negative breast cancer [10] Executive Commentary - Dr. John Friend, CEO of Kazia Therapeutics, expressed optimism about the preliminary results, highlighting the rarity of confirmed complete responses in metastatic TNBC and the potential of paxalisib to enhance existing immunotherapy regimens [11]