Celcuity Inc. has fully enrolled the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial, evaluating gedatolisib for advanced breast cancer. Data analysis from a Phase 1b trial showed a median progression-free survival (PFS) of 14.6 months in HR+/HER2-/PIK3CA-mutated patients. The company expects to report topline data in late Q1 or Q2 2026. Patients receiving gedatolisib combined with palbociclib and fulvestrant had a median PFS of 14.6 months, with an objective response rate (ORR) of 48%. The Phase 3 trial VIKTORIA-2 is currently enrolling patients for further evaluation.

Read more at GlobeNewswire: Celcuity Provides Update on Status of the PIK3CA Mutated