Celcuity Publishes Efficacy Results of Gedatolisib Clinical Trial

Celcuity announced publication of efficacy and safety results from the PIK3CA wild-type 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, human epidermal growth factor receptor 2 negative PIK3CA WT advanced breast cancer, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The objective response rate of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia; stomatitis rash; and hyperglycemia. The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia, leukopenia, and pneumonitis. TRAEs led to the discontinuation of study treatment in 2.3% of patienThe U.S. FDA has granted Priority Review of Celcuity's New Drug Application for gedatolisib and assigned a Prescription Drug User Fee Act goal date of July 17, 2026.