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

Core Insights - Celcuity Inc. announced significant efficacy results from the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, showing a 76% reduction in disease progression or death with the gedatolisib triplet compared to fulvestrant [1][5] - The trial focused on patients with hormone receptor positive, HER2 negative, PIK3CA wild-type advanced breast cancer who had previously progressed on CDK4/6 inhibitors and aromatase inhibitors [1][2] Efficacy Results - In the PIK3CA wild-type cohort, the median progression-free survival (PFS) for the gedatolisib triplet was 9.3 months, compared to 2.0 months for fulvestrant, representing a 7.3-month improvement (HR=0.24; p<0.0001) [3] - The objective response rate (ORR) for the gedatolisib triplet was 31.5%, while the ORR for fulvestrant was only 1% [3] - For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months for fulvestrant, an improvement of 5.4 months (HR=0.33; p<0.0001) [3] Safety Profile - The gedatolisib triplet and doublet were generally well tolerated, with low-grade treatment-related adverse events (TRAEs) [4] - Common grade 3 TRAEs included neutropenia (52.3% for triplet, 0% for doublet, 0.8% for fulvestrant) and stomatitis (19.2% for triplet, 12.3% for doublet, 0% for fulvestrant) [4] - TRAEs led to treatment discontinuation in 2.3% of patients in the gedatolisib triplet group and 3.1% in the gedatolisib doublet group, with no discontinuations in the fulvestrant group [4] Regulatory Status - The U.S. FDA has granted Priority Review for Celcuity's New Drug Application for gedatolisib, with a Prescription Drug User Fee Act goal date set for July 17, 2026 [5] Background on Breast Cancer - Breast cancer is the second most common cancer globally, with over two million cases diagnosed in 2022 [6] - HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases, and therapies targeting the PI3K/AKT/mTOR pathway are crucial for treatment [6][7] About Gedatolisib - Gedatolisib is a multi-target PAM inhibitor that comprehensively blocks the PI3K/AKT/mTOR pathway, differentiating it from single-target inhibitors [9][10] - It has shown comparable potency in both PIK3CA-mutant and wild-type breast tumor cells in early clinical data [9]