Celcuity Gedatolisib Phase 3 Trial Shows Superior PFS & ORR in Breast Cancer
Celcuity Inc. announced detailed positive efficacy and safety results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- PIK3CA mutated advanced breast cancer. The gedatolisib-triplet regimen significantly reduced the risk of disease progression or death by 50% (HR=0.50) and nearly doubled median progression-free survival to 11.1 months compared to alpelisib plus fulvestrant (5.6 months). Both gedatolisib regimens demonstrated robust responses and favorable safety profiles, with lower discontinuation rates due to adverse events. The company plans to submit these data to the FDA as a supplemental New Drug Application (sNDA) and anticipates potential FDA approval in Q3 2026.
Key Highlights
- Gedatolisib-triplet reduced disease progression/death risk by 50% (HR=0.50) vs. alpelisib.
- Median PFS for gedatolisib-triplet was 11.1 months vs. 5.6 months for alpelisib.
- Gedatolisib-doublet median PFS was 11.3 months vs. 5.6 months for alpelisib.
- Gedatolisib-triplet ORR was 48.9% and median DoR 15.7 months.
- Gedatolisib-doublet ORR was 35.7% and median DoR 24.2 months.
- Discontinuation due to TRAEs: 2.6% (triplet), 3.8% (doublet), 7.1% (alpelisib).
- Celcuity plans sNDA submission; anticipates potential FDA approval in Q3 2026.
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