Kazia Therapeutics widens Paxalisib trial to HR+/HER2- breast cancer based on promising preclinical data
Executive summary: Kazia Therapeutics expanded its Paxalisib clinical trial to test the drug in HR+/HER2- breast cancer, adding a three‑arm study that pairs Paxalisib with fulvestrant and palbociclib versus standard‑of‑care. The expansion could open a new therapeutic avenue for a large breast‑cancer subtype and potentially increase Kazia’s pipeline value if the combination shows efficacy.
Who is involved: Kazia Therapeutics (sponsor), clinical trial investigators, and patients with HR+/HER2- breast cancer.
Likely next: Enrollment of patients into the expanded trial arms, with interim safety and efficacy read‑outs expected within the next 12‑18 months.
Kazia Therapeutics announced an expansion of its ongoing Paxalisib clinical trial to include hormone receptor-positive, HER2-negative breast cancer patients. The move is supported by preclinical data showing that Paxalisib combined with standard-of-care therapy demonstrated statistically significant antitumor activity and a tolerable safety profile. The expansion adds a three‑arm study evaluating Paxalisib plus fulvestrant with palbociclib against standard‑of‑care alone. This development positions Kazia to explore a broader indications for its PI3K‑beta inhibitor in breast oncology.
Timeline
- — Kazia Therapeutics Expands Paxalisib Clinical Trial into HR+/HER2- Breast Cancer, Supported by Preclinical Data Showing Strong Clinical Activity and Safety in HR+ Breast Cancer (PR Newswire)
Analysis — what this means
Sectors affected
- oncology drug development
- breast cancer therapeutics