Celcuity announces clinically meaningful improvement in both progression-free survival primary endpoints from PIK3CA wild-type cohort of phase 3 VIKTORIA-1 trial
- Gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17--0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant
- Gedatolisib + fulvestrant ("gedatolisib doublet") reduced the risk of progression or death by 67% vs. fulvestrant (HR=0.33; 95% CI: 0.24--0.48; p<0.0001). Median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant
- The efficacy results establish several new milestones in the history of drug development for HR+/HER2- advanced breast cancer
- Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of Celcuity's Phase 1b trial in ABC patients and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC
- The favorable safety profile with the gedatolisib triplet and gedatolisib doublet was better than observed in the Phase 1b trial in ABC, including lower rates of hyperglycemia and stomatitis
- Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.