Kazia Therapeutics Reports Rare Immune-Complete Response in Stage IV Breast Cancer: What Does This Mean for Future Oncology Treatments?

Breakthrough Response: Initial iCR Achieved in Metastatic Triple-Negative Breast Cancer

On November 18, 2025, Kazia Therapeutics made headlines after reporting an initial immune-complete response (iCR) in a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized expanded access protocol. The regimen—combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy—resulted in the complete metabolic resolution of all cancerous lesions, verified by PET/CT scan at three months.

What makes this particularly significant? Complete responses in metastatic TNBC are exceptionally rare across all major therapies, with pembrolizumab monotherapy delivering complete response rates of only 0.6-4% and even leading agents like sacituzumab govitecan achieving around 2-4% in large clinical trials. Against this backdrop, the radiologic finding of an iCR in this aggressive cancer subtype is noteworthy and stands out versus historical expectations.

Table: Comparison of Complete Response Rates in Metastatic TNBC Therapies

Scientific Presentations Spotlight Kazia's Research Progress

Kazia is preparing for significant visibility in the oncology research community, with two scientific presentations on paxalisib and the NDL2 program at the 2025 Brisbane Cancer Conference. In December, two presentations at the globally recognized San Antonio Breast Cancer Symposium (SABCS) will cover both innovative liquid biopsy approaches and results from a Phase 1b study combining paxalisib with immunotherapies or olaparib for advanced breast cancer.

• November 27, 2025: Focus on overcoming metastasis and resistance in TNBC through epigenetic and immunogenic strategies (Brisbane Cancer Conference)
• December 10-14, 2025: Liquid biopsy tracking of PI3K-mTOR residual disease and safety/efficacy of novel combination regimens (SABCS)

Next-Generation Immuno-Oncology: PD-L1 Degrader Program Advances

Kazia’s NDL2 PD-L1 degrader, developed in collaboration with QIMR Berghofer, is on track for IND-enabling studies in early 2026. Unlike current checkpoint inhibitors, this approach targets and degrades resistant PD-L1 proteins, potentially addressing limitations seen with first-generation immunotherapies.

GBM Regulatory Strategy Targets Efficient Approval Pathway

Following encouraging overall survival results from paxalisib in glioblastoma (GBM) trials, Kazia is preparing to request a Type C meeting with the FDA. The goal is to align its clinical development and potential new drug application under the Project FrontRunner regulatory framework, potentially accelerating approval in the front-line setting for GBM patients.

Nasdaq Listing Challenge Poses Uncertainty, but Strategic Actions Are Underway

Kazia has been notified of non-compliance with the minimum market value requirement for continued Nasdaq listing, with the potential for suspension or delisting. The company is actively pursuing remedies, including a planned hearing to seek additional time for compliance or alternative solutions.

Key Takeaways: Kazia Pushes Oncology Boundaries Amid Regulatory and Market Headwinds

The report of an initial immune-complete response in stage IV TNBC highlights a potentially pivotal role for Kazia’s paxalisib in aggressive cancers that historically have poor response rates. With major conference presentations scheduled and innovative new assets progressing, the company’s scientific pipeline is clearly advancing.

However, looming Nasdaq compliance issues add financial and strategic pressure to the story. As Kazia navigates clinical milestones and regulatory hurdles, investors and researchers will want to keep an eye on forthcoming trial data, confirmatory scans for the reported iCR, and updates on regulatory proceedings.

For Those Following Kazia

If you are watching developments in cancer drug innovation, this is a company worth following in 2026. With data-driven progress and the potential for landmark clinical responses, Kazia’s next chapter may shape how the industry thinks about hard-to-treat cancers—and the pathways to bring new therapies to patients faster.

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