Celcuity Inc., a clinical-stage biotechnology company, announced updated results from the randomized, Phase 3 VIKTORIA-1 trial evaluating gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, in adults with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer. The data were presented at the 2025 San Antonio Breast Cancer Symposium. Results showed that, for patients whose time to progression on prior therapy exceeded 18 months, the median progression-free survival $(PFS)$ was 12.4 months for the gedatolisib triplet (gedatolisib + palbociclib + fulvestrant), 10.0 months for the gedatolisib doublet (gedatolisib + fulvestrant), and 1.9 months for fulvestrant alone. Among patients in the U.S., Canada, Western Europe, and Asia Pacific, the median PFS was 16.6 months with the triplet regimen and 7.1 months with the doublet, compared to 1.9 months for fulvestrant. Measures to mitigate stomatitis were generally effective, with most patients experiencing resolution to a lower grade within two weeks.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9600898-en) on December 11, 2025, and is solely responsible for the information contained therein.
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