#Australia #Sydney #TNBC #Kazia Therapeutics #Immuno-Oncology

Kazia Therapeutics Makes Strides in Cancer Treatment

Kazia Therapeutics Limited, a Sydney-based company focused on oncology drug development, has made headlines with its recent breakthroughs in treating stage IV triple-negative breast cancer (TNBC). In a significant announcement made on November 18, 2025, the company revealed that a patient undergoing a novel treatment combining paxalisib with pembrolizumab (Keytruda) and standard chemotherapy achieved an initial immune-complete response (iCR). This achievement is exceptional given the aggressive nature of metastatic TNBC, where complete responses are exceedingly rare.

The announcement follows an earlier report on October 2, 2025, where the same patient displayed an impressive 86% reduction in tumor burden after just three weeks of treatment. A PET/CT scan conducted approximately three months post-treatment further validated the efficacy, demonstrating complete metabolic resolution of all identified lesions. The patient will be closely monitored, with plans for follow-up scans to adhere to immune-based response assessment guidelines.

Dr. John Friend, the CEO of Kazia, expressed optimism regarding this outcome, stating, “Observing an initial complete response in a patient with metastatic triple-negative breast cancer is an extremely encouraging clinical finding.” He noted that while this result is from an expanded-access case, it aligns with their hypothesis that paxalisib could significantly boost anti-tumor immunity when used in conjunction with checkpoint inhibitors.

Q4 Business Update Highlights

In conjunction with the promising patient results, Kazia also provided updates on its pipeline and strategic direction, particularly regarding future presentations and collaborations:

Upcoming Scientific Presentations

Kazia announced the acceptance of two significant presentations at the 2025 Brisbane Cancer Conference and the San Antonio Breast Cancer Symposium (SABCS). The Brisbane conference, set for late November, will feature talks by prominent researchers on advanced cancer treatments, including topics like epigenetic pathways to combat immunotherapy resistance. SABCS is anticipated to attract over 10,000 experts in cancer research, with Kazia presenting critical findings relevant to advanced breast cancer treatments.

Advancement of NDL2 Program

Kazia is also progressing its NDL2 PD-L1 degrader program toward IND-enabling studies, expected to commence in early 2026. This innovative approach aims to address resistance mechanisms associated with existing checkpoint inhibitors, potentially leading to more effective therapies in immuno-oncology.

Progress in Glioblastoma Program

Additionally, Kazia plans to request a Type C meeting with the FDA to discuss the overall survival data for paxalisib in glioblastoma patients. Dr. Friend indicated that the data strongly supports continued discussions with the FDA and may allow for a more efficient regulatory strategy.

Despite navigating regulatory challenges, including a notice from Nasdaq regarding compliance issues, Kazia remains steadfast in its commitment to innovation in cancer therapies. With plans to appeal the Nasdaq ruling, the company is evaluating various corporate strategies to enhance compliance with market standards.

As Kazia Therapeutics continues its journey in pioneering cancer treatments, the remarkable initial findings with paxalisib not only demonstrate clinical promise for patients but also highlight the company's potential to significantly impact the oncology landscape. For more updates, follow Kazia on their official channels and stay tuned for further announcements regarding their ongoing research and developments.