Kazia Therapeutics Limited (NASDAQ:KZIA), an oncology-focused drug development company based in Sydney, Australia, announced on Thursday new data showing that its lead asset, paxalisib, achieved a 100% clinical benefit rate in six evaluable patients with Stage IV triple-negative breast cancer (TNBC).

In the trial, five of the six patients achieved an objective response -- a measurable 30% or greater reduction in tumour burden after treatment -- including one complete response and four partial responses, resulting in an objective response rate of 83%. The remaining patient achieved stable disease. The company said that these results were achieved with the convenience of oral dosing and a favourable safety and tolerability profile, with no paxalisib-related serious adverse events and no grade 3 or higher hyperglycaemia, stomatitis or mucositis, toxicities commonly associated with PI3K/mTOR pathway inhibition.

Clinical responses were observed across a broad range of metastatic disease sites, including lung, liver, bone, lymph node and central nervous system target lesions, with responses emerging as early as approximately three months post-randomisation. The marker findings provide evidence of improved overall immune function across all patients.

Enrolment in the company's ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab (Keytruda) and chemotherapy in advanced metastatic TNBC is expected to be completed by July 2027, with interim clinical updates anticipated throughout 2026 and 2027.