Paxalisib

Aug. 27, 2026: Kazia Therapeutics (NASDAQ: KZIA) reported early data from an ongoing Phase 1b trial of paxalisib in combination with pembrolizumab and chemotherapy in advanced metastatic triple-negative breast cancer. In six evaluable Stage IV TNBC patients, the clinical benefit rate was 100%: five had objective responses (ORR 83%), including one complete response and four partial responses, and one had stable disease.

Responses were seen in lung, liver, bone, lymph node, and CNS lesions, with onset as early as about three months post-randomization. One 44-year-old patient achieved a complete metabolic response and has had no evidence of disease since November 2025, with durability continuing through the latest assessment.

Translational findings showed reductions in terminally exhausted CD8+ T cells in all six patients, with a median 51% reduction within about three weeks, while total CD8+ counts were unchanged. All six also had reductions in metastasis-associated circulating tumor cell clusters, with a median 83% reduction within six to seven weeks. No treatment-related serious adverse events were observed, and no grade 3+ hyperglycemia, stomatitis, or mucositis were reported.

Enrollment is expected to complete by July 2027, with interim clinical updates anticipated throughout 2026 and 2027.