Celcuity reports PIK3CA WT cohort results from VIKTORIA-1 trial

Celcuity published efficacy and safety results for the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, reporting longer median progression-free survival and higher objective response rates with gedatolisib-containing regimens versus fulvestrant; the U.S. FDA has granted Priority Review with a PDUFA date of July 17, 2026.

Celcuity announced publication of efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial of gedatolisib, reported in the Journal of Clinical Oncology. The cohort included patients with hormone receptor positive, HER2-negative advanced breast cancer after progression on or after a CDK4/6 inhibitor and an aromatase inhibitor. The report compares gedatolisib-containing triplet and doublet regimens to fulvestrant and summarizes efficacy and treatment-related adverse events. The U.S. FDA has granted Priority Review of Celcuity's New Drug Application for gedatolisib with a Prescription Drug User Fee Act goal date of July 17, 2026. Key findings: - The gedatolisib triplet produced a median progression-free survival (PFS) of 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. - The objective response rate (ORR) for the gedatolisib triplet was 31.5% compared to 1% with fulvestrant, and the median duration of response (DOR) for the triplet was 17.5 months. - The gedatolisib doublet yielded a median PFS of 7.4 months versus 2.0 months with fulvestrant, with an ORR of 28.3% and a median DOR of 12.0 months. - The median DOR for fulvestrant was not determinable because there was only one objective response in that arm. - The gedatolisib triplet and doublet were reported as generally well tolerated with mostly low-grade treatment-related adverse events; common grade 3 TRAEs included neutropenia, stomatitis, rash, and hyperglycemia, and primary grade 4 TRAEs included neutropenia, leukopenia, and pneumonitis. TRAEs led to discontinuation of study treatment in 2.3% of patients. Summary: The published data report longer median PFS and higher ORR with gedatolisib-containing regimens compared with fulvestrant in the PIK3CA wild-type cohort of VIKTORIA-1 and describe the safety profile observed in the trial. The U.S. FDA has assigned a Priority Review with a PDUFA goal date of July 17, 2026, for gedatolisib; further regulatory evaluation is pending.