Kazia Expands Paxalisib Trial Enrollment from 12 to 36 TNBC Patients
KZIA•Kazia Therapeutics is increasing enrollment in its Phase 1b triple negative breast cancer trial of paxalisib plus pembrolizumab and chemotherapy from 12 to 36 patients following encouraging safety and tolerability. The expansion will assess objective response rate, progression-free survival and translational biomarkers, with clinical updates through 2026 and into 2027.
1. Trial Expansion Details
Kazia has increased planned enrollment in its ongoing Phase 1b trial for advanced triple negative breast cancer from 12 to 36 patients after observing compelling safety and tolerability. The expansion aims to strengthen statistical power for evaluating dose optimization and safety across multiple cohorts.
2. Combination Regimen & Objectives
The study administers paxalisib alongside pembrolizumab and standard chemotherapy regimens to explore synergistic effects on tumor biology. Key endpoints include objective response rate, progression-free survival and translational biomarker analyses to gauge clinical activity and immune modulation.
3. Outlook & Next Steps
Additional safety, tolerability and preliminary efficacy data are expected throughout 2026 into 2027, informing the design of future pivotal studies. Withdrawal of ASCO abstracts reflects strategic intellectual property protection rather than clinical concerns as Kazia advances regulatory discussions.
