Core Insights - Celcuity Inc. announced positive topline results from the Phase 3 VIKTORIA-1 clinical trial for gedatolisib in combination with fulvestrant, showing significant improvements in progression-free survival (PFS) for patients with HR+/HER2- advanced breast cancer [2][5][9] Efficacy Results - The gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median PFS of 9.3 months versus 2.0 months, representing an incremental improvement of 7.3 months [3][6][7] - The gedatolisib doublet (gedatolisib + fulvestrant) reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months for fulvestrant, an incremental improvement of 5.4 months [4][6][7] Historical Significance - The hazard ratios for both the gedatolisib triplet and doublet are the most favorable reported in any Phase 3 trial for HR+/HER2- advanced breast cancer [7] - The incremental improvements in median PFS for both regimens are unprecedented for patients receiving at least their second line of therapy in this category [7][8] Safety Profile - Treatment discontinuation due to treatment-related adverse events for both the gedatolisib triplet and doublet was lower than observed in previous trials, indicating a favorable safety profile [6][8] - Lower rates of hyperglycemia and stomatitis were reported compared to earlier studies, suggesting better tolerability of the gedatolisib regimens [6][8] Future Developments - Full data from the VIKTORIA-1 trial will be presented at an upcoming medical conference, and Celcuity plans to submit a New Drug Application for gedatolisib to the FDA in Q4 2025 [5][9]