Clinical TrialMay 14, 2026, 07:32 AM
Celcuity Expands VIKTORIA-2 Trial for Gedatolisib; Files Subcutaneous Patent
AI Summary
Celcuity Inc. announced significant amendments to its Phase 3 VIKTORIA-2 clinical trial for gedatolisib, expanding its scope to include first-line treatment for patients with endocrine-sensitive HR+/HER2- advanced breast cancer. The trial will now feature two independent studies for endocrine-resistant and endocrine-sensitive patients, with efficacy analyses evaluating the entire intent-to-treat population. The company also submitted a patent application for a subcutaneous formulation of gedatolisib to support long-term lifecycle development.
Key Highlights
- VIKTORIA-2 Phase 3 trial expanded to include endocrine-sensitive HR+/HER2- ABC patients.
- Trial now comprises two studies: endocrine-resistant (Study 1, ~440 patients) and endocrine-sensitive (Study 2, ~740 patients).
- Efficacy analyses for both studies will evaluate the entire intent-to-treat population (WT and MT).
- Primary endpoints for VIKTORIA-2 are progression-free survival (PFS) per RECIST 1.1 criteria.
- FDA provided feedback and alignment on the amended Phase 3 trial design.
- Phase 1b data for endocrine-sensitive patients showed 48.6 months median PFS and 79% objective response rate.
- Celcuity submitted a patent application for a subcutaneous formulation of gedatolisib.
- NDA for gedatolisib in PIK3CA WT ABC has a PDUFA goal date of July 17, 2026.