Kazia Therapeutics(US:KZIA) Prnewswire·2025-11-18 21:15Core Insights - Kazia Therapeutics Limited announced a significant clinical milestone with a patient suffering from stage IV triple-negative breast cancer (TNBC) achieving an initial immune-complete response (iCR) after treatment with paxalisib, pembrolizumab (Keytruda®), and standard chemotherapy [1][5]. Clinical Developments - The patient experienced an 86% reduction in tumor burden after three weeks of treatment, with a PET/CT scan showing complete metabolic resolution of all previously identified lesions after approximately three months [2]. - Complete responses in stage IV metastatic TNBC are rare, with pembrolizumab monotherapy showing complete response rates of only 0.6–4% in previous studies [3]. - The initial iCR observed in this case is considered a highly unusual event, suggesting enhanced biological activity of the combination regimen [4]. Future Plans and Presentations - Kazia will present findings related to paxalisib and its NDL2 programs at the upcoming Brisbane Cancer Conference on November 27-28, 2025, and at the San Antonio Breast Cancer Symposium from December 10-14, 2025 [6][7]. - The company is advancing its NDL2 PD-L1 degrader program towards IND-enabling studies anticipated in early 2026, aiming to address resistance mechanisms in immuno-oncology [10]. - Kazia plans to request a Type C meeting with the FDA to discuss overall survival findings from clinical studies involving paxalisib in glioblastoma, aligning with the Project FrontRunner framework [11]. Regulatory and Compliance Updates - Kazia received a notice from Nasdaq regarding non-compliance with the Market Value of Listed Securities requirement, with a deadline to regain compliance by November 10, 2025 [12]. - Following the deadline, Kazia received a staff determination letter indicating non-compliance, but intends to request a hearing to address the situation [13].