Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer

Core Insights - Celcuity Inc. announced significant efficacy and safety results from the Phase 3 VIKTORIA-1 clinical trial of gedatolisib for advanced breast cancer, showing a 76% reduction in disease progression risk with the triplet therapy compared to fulvestrant [1][3][6] Efficacy Results - The gedatolisib triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, an improvement of 7.3 months over fulvestrant, with a hazard ratio (HR) of 0.24 [3][6] - The objective response rate (ORR) for the triplet was 31.5%, while the doublet showed an ORR of 28.3% [3][6] - For the gedatolisib doublet, the median PFS was 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33 [3][6] Safety Profile - Hyperglycemia occurred in 9.2% of patients on the triplet and 11.5% on the doublet, with treatment discontinuation due to adverse events at 2.3% and 3.1%, respectively [5][7] - The most common grade 3 treatment-related adverse events included neutropenia (52.3% for triplet), stomatitis (19.2% for triplet), and hyperglycemia (2.3% for triplet) [7] Clinical Significance - The results from the VIKTORIA-1 trial represent a potential new standard of care for patients with HR+/HER2- advanced breast cancer who have progressed after CDK4/6 inhibitor treatment [7][9] - Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to show positive Phase 3 results in this patient population [6][9] Future Developments - Celcuity has initiated a rolling New Drug Application (NDA) submission to the FDA, targeting completion in Q4 2025 [9] - The PIK3CA mutant cohort of the VIKTORIA-1 trial is fully enrolled, with topline data expected in late Q1 or Q2 2026 [9]