Celcuity Inc. announced on July 28, 2025, highly positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 clinical trial. The trial evaluated gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/HER2- advanced breast cancer who had progressed after prior CDK4/6 inhibitor and aromatase inhibitor treatment.
The gedatolisib triplet regimen (gedatolisib, fulvestrant, and palbociclib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). It reduced the risk of disease progression or death by 76% compared to fulvestrant alone, with a hazard ratio of 0.24 (p<0.0001).
The median PFS for the triplet was 9.3 months versus 2.0 months for fulvestrant, an incremental improvement of 7.3 months. The gedatolisib doublet (gedatolisib and fulvestrant) also showed significant improvement, reducing the risk of progression or death by 67% (HR 0.33, p<0.0001), with a median PFS of 7.4 months, an incremental improvement of 5.4 months.
These hazard ratios and improvements in median PFS are described as unprecedented in HR+/HER2- advanced breast cancer. Treatment discontinuation rates due to adverse events for both gedatolisib regimens were lower than observed in previous trials and approved drug combinations.
The company plans to submit a New Drug Application (NDA) for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025, based on these positive results. Topline data for the PIK3CA mutation cohort of VIKTORIA-1 is expected by the end of 2025.
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