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Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium
For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib +
About this update from Celcuity Inc.
[{"type":"text","content":"For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrantFor patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 months for fulvestrantMeasures to mitigate stomatitis were generally effective; most patients experienced resolution to a lower grade of stomatitis within 2 weeks MINNEAPOLIS, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR (“PAM”) inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA wild-type (“WT”), advanced breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The additional study results were presented in an oral presentation session at the 2025 San Antonio Breast Cancer Symposium (“SABCS”) today, Thursday, December 11. Efficacy was further evaluated in several additional patient sub-groups. For patients whose time to progression on immediate prior therapy was >18 months, representing nearly half of those enrolled, median PFS was 12.4 months (HR=0.17; 95% CI: 0.11-0.28) with the gedatolisib triplet and 10.0 months (HR=0.19; 95% CI: 0.12-0.31) with the gedatolisib doublet versus 1.9 months for fulvestrant. For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, representing nearly 60% of those enrolled, median PFS was 16.6 months (HR=0.14; 95% CI: 0.09-0.26) with the gedatolisib triplet and 7.1 months (HR=0.36; 95% CI: 0.24-0.57) with the gedatolisib doublet versus 1.9 months for fulvestrant. Additional safety analyses were also performed. For patients who experienced stomatitis, measures to mitigate it were generally effective. The median time to improvement to a lower grade of stomatitis for patients with Grade 2 or 3 stomatitis who received...