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Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology
As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the
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As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the risk of disease progression or death versus fulvestrant by 76% and 67%, respectively MINNEAPOLIS , March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced publication of efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology . The cohort consists of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) PIK3CA WT advanced breast cancer (“ABC”), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The publication is titled “VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer.” “VIKTORIA-1 is the first Phase 3 study to show a significant improvement in median progression-free survival with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type HR+/HER2- advanced breast cancer who previously received a CDK4/6 inhibitor,” said Sara Hurvitz , MD, lead study author and Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center , Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology , University of Washington , Department of Medicine . In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival (“PFS”) with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p