Kazia Therapeutics报告paxalisib治疗三阴性乳腺癌Phase 1b试验6名患者中83%客观缓解率

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SYDNEY - Kazia Therapeutics Limited (NASDAQ:KZIA) reported today that six evaluable patients with Stage IV triple-negative breast cancer showed clinical benefit in an ongoing Phase 1b trial of its drug candidate paxalisib, according to a press release statement.
Five of the six patients achieved an objective response, defined as a 30% or greater reduction in tumor burden, including one complete response and four partial responses, representing an 83% objective response rate. The remaining patient achieved stable disease.
The trial is evaluating paxalisib in combination with pembrolizumab and chemotherapy. Clinical responses were observed across metastatic disease sites including lung, liver, bone, lymph node and central nervous system lesions, with responses emerging approximately three months post-randomization.
One 44-year-old woman achieved a complete metabolic response with no evidence of disease since November 2025, which has remained durable through the most recent assessment.
All six patients demonstrated reductions in circulating tumor cell clusters and terminally exhausted T cells, with median reductions of 83% and 51% respectively. The company stated that total CD8+ T cell counts remained unchanged, suggesting existing cells may be regaining function rather than being replaced.
No paxalisib-related serious adverse events were observed, and no grade 3 or higher hyperglycemia, stomatitis or mucositis occurred.
Enrollment in the Phase 1b study is expected to be completed by July 2027, with interim clinical updates anticipated throughout 2026 and 2027.
Paxalisib was licensed from Genentech in late 2016 and has been the subject of over 15 clinical trials. The drug has received Orphan Drug Designation and Fast Track Designation from the FDA for glioblastoma, and Fast Track Designation for solid tumor brain metastases with PI3K pathway mutations.
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