Kazia Therapeutics Updates on TNBC Clinical Trial Progress

Kazia Therapeutics provided a clinical update from its ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy in patients with late-stage, metastatic triple-negative breast cancer, or TNBC. To date, three patients with metastatic TNBC treated with paxalisib-based regimens have demonstrated meaningful clinical responses, including two partial responses in trial participants and one confirmed complete metabolic response in a patient treated under an expanded access program. 2 of 2 evaluable patients enrolled in the Phase 1b trial achieved partial responses. One advanced metastatic TNBC patient achieved a confirmed complete metabolic response following re-treatment with pembrolizumab/chemotherapy plus paxalisib. Responses observed in patients with visceral disease and multi-organ metastases. Median time on treatment to date is approximately 6.1 months, with all patients continuing on therapy at the time of this update. Paxalisib continues to demonstrate a generally favorable safety and tolerability profile when combined with pembrolizumab and chemotherapy at the 30 mg daily dose. Approximately 75% of adverse events were assessed as unlikely or unrelated to paxalisib. The paxalisib-related AEs were expected and predominantly mild to moderate, consistent with prior studies. The company expects to activate two additional clinical sites by April 2026, with two further sites planned for mid-2026. Kazia continues to anticipate the targeted enrollment of twelve TNBC pts target by the end of 2026 and topline data readout in early 2027.