Kazia reports results from patient with stage IV TNBC treated with pembrolizumab

Kazia Therapeutics (KZIA) announced that a patient with stage IV triple-negative breast cancer, or TNBC, treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab, or Keytruda, and standard chemotherapy has achieved an initial immune-complete response, or iCR, per iRECIST criteria. This outcome suggests a profound radiologic response in a highly aggressive metastatic cancer subtype. This development builds upon Kazia’s October 2 announcement reporting an 86% reduction in tumor burden after only three weeks of treatment in the same patient. A PET/CT scan performed after approximately three months of therapy demonstrated complete metabolic resolution of all previously identified lesions, consistent with an initial iCR. Complete responses in stage IV metastatic TNBC are exceedingly uncommon across many therapeutic classes, including immunotherapy, chemotherapy, and antibody-drug conjugates. For example, pembrolizumab monotherapy has demonstrated complete response rates of approximately 0.6-4% in metastatic TNBC across KEYNOTE studies, and even the most active approved agents-such as sacituzumab govitecan-have reported complete response rates of only ~2-4% in large Phase 2 and Phase 3 trials. Q4 business update includes: Kazia Announces upcoming presentations related to paxalisib and NDL2 programs; NDL2 PD-L1 Degrader Program: Advancing Toward IND-Enabling Studies anticipated in Early 2026; GBM Program: Advancing Toward a FDA Type C Meeting Request Following Strong Overall Survival Signals.