Kazia Therapeutics Unveils Promising Early Results from Phase 1b Study of Paxalisib in Late-Stage Triple-Negative Breast Cancer
Kazia Therapeutics, an oncology-focused biopharmaceutical company listed on the NASDAQ (KZIA), has made significant strides in the treatment of late-stage metastatic triple-negative breast cancer (TNBC). On January 27, 2026, the company shared exciting preliminary results from its ongoing Phase 1b clinical trial, which tests the efficacy of Paxalisib alongside pembrolizumab and chemotherapy in patients diagnosed with advanced breast cancer.
As of this announcement, three patients undergoing treatment with Paxalisib have exhibited noteworthy clinical responses. Among these patients, there were two instances of partial responses (PRs) documented within the trial framework and one confirmed complete metabolic response (CR) from a patient who received treatment under an expanded access program. The integration of Paxalisib appears to display potential benefits in cases characterized by visceral component involvement and multi-organ metastases.
Currently, participants are experiencing an average treatment duration of approximately 6.1 months, with all patients actively continuing on their designated treatment regimens. The data thus far suggest that Paxalisib maintains a favorable safety profile, exhibiting tolerability when administered at a daily dose of 30 mg in conjunction with pembrolizumab and chemotherapy.
The clinical trial has revealed promising outcomes across several participants:
In light of the compelling results, Kazia anticipates expanding its clinical study by activating two additional centers by April 2026, with further plans in mid-2026. The recruitment target for the trial aims to achieve twelve participants diagnosed with TNBC by the end of 2026, followed by the expected topline results in early 2027. The trials focus not just on TNBC, but also on other cohorts including hormone receptor-positive, HER2-negative breast cancer and earlier-stage TNBC populations where the PI3K/mTOR pathway plays a crucial role.
Kazia Therapeutics believes that Paxalisib’s orally administered regimen offers a convenient treatment pathway with minimal burden to patients—an important consideration as the company seeks to broaden the application of this medication in breast cancer treatment. Dr. John Friend, M.D., the CEO of Kazia, emphasized the significance of these preliminary findings, underscoring the rarity of confirmed complete responses in advanced breast cancer settings, particularly in patients with prior treatment failures.
Overall, the emerging data from this study signify a potential enhancement in therapeutic options for patients battling difficult forms of cancer, providing hope in a field that continuously seeks innovative solutions to battle resilient disease forms like metastatic TNBC. As Kazia Therapeutics progresses through its clinical phases, updates will be made available to keep stakeholders informed of advancements and outcomes related to Paxalisib and its emerging role in oncology.
Clinical Update and Responses
As of this announcement, three patients undergoing treatment with Paxalisib have exhibited noteworthy clinical responses. Among these patients, there were two instances of partial responses (PRs) documented within the trial framework and one confirmed complete metabolic response (CR) from a patient who received treatment under an expanded access program. The integration of Paxalisib appears to display potential benefits in cases characterized by visceral component involvement and multi-organ metastases.
Currently, participants are experiencing an average treatment duration of approximately 6.1 months, with all patients actively continuing on their designated treatment regimens. The data thus far suggest that Paxalisib maintains a favorable safety profile, exhibiting tolerability when administered at a daily dose of 30 mg in conjunction with pembrolizumab and chemotherapy.
Patient Case Highlights
The clinical trial has revealed promising outcomes across several participants:
- - Patient 1: A 61-year-old female began treatment with Paxalisib at 30 mg daily in June 2025, pairing it with pembrolizumab and gemcitabine/carboplatin. Following nine cycles, imaging confirmed continued tumor size reduction, culminating in a documented partial response following iRECIST criteria. The patient remains active within the study framework.
- - Patient 2: A 47-year-old female exhibited extensive metastasis across several organs, initiating a similar treatment combination in October 2025. After three cycles, radiological assessments revealed a partial response, including total resolution of a specific lung lesion. She continues to be monitored in the study.
- - Patient 3: An intriguing case was that of a 44-year-old female previously treated with pembrolizumab/chemotherapy who saw disease progression early in 2025. Despite being ineligible for the trial due to earlier exposure, she was re-treated under supervision with Paxalisib, leading to a complete metabolic response confirmed by follow-up imaging in January 2026.
Ongoing and Future Plans
In light of the compelling results, Kazia anticipates expanding its clinical study by activating two additional centers by April 2026, with further plans in mid-2026. The recruitment target for the trial aims to achieve twelve participants diagnosed with TNBC by the end of 2026, followed by the expected topline results in early 2027. The trials focus not just on TNBC, but also on other cohorts including hormone receptor-positive, HER2-negative breast cancer and earlier-stage TNBC populations where the PI3K/mTOR pathway plays a crucial role.
Kazia Therapeutics believes that Paxalisib’s orally administered regimen offers a convenient treatment pathway with minimal burden to patients—an important consideration as the company seeks to broaden the application of this medication in breast cancer treatment. Dr. John Friend, M.D., the CEO of Kazia, emphasized the significance of these preliminary findings, underscoring the rarity of confirmed complete responses in advanced breast cancer settings, particularly in patients with prior treatment failures.
Overall, the emerging data from this study signify a potential enhancement in therapeutic options for patients battling difficult forms of cancer, providing hope in a field that continuously seeks innovative solutions to battle resilient disease forms like metastatic TNBC. As Kazia Therapeutics progresses through its clinical phases, updates will be made available to keep stakeholders informed of advancements and outcomes related to Paxalisib and its emerging role in oncology.
Topics Health）
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