Celcuity Reports Major Breakthrough in Advanced Breast Cancer Trial Results

MINNEAPOLIS, July 28, 2025 (GLOBE NEWSWIRE) — Celcuity Inc. (NASDAQ: CELC), a biotechnology company focused on targeted therapies, has announced positive topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial. The trial evaluated the effectiveness of gedatolisib, with and without palbociclib, in treating hormone receptor-positive, HER2-negative advanced breast cancer.

The results revealed that the gedatolisib triplet therapy reduced the risk of disease progression by an impressive 76%, achieving a median progression-free survival (mPFS) of 9.3 months compared to just 2.0 months for fulvestrant alone. The gedatolisib doublet also showed promising results, with a 67% reduction in progression risk and a median PFS of 7.4 months.

The improvements in median PFS for both treatment regimens are unprecedented in this type of breast cancer. The triplet regimen showed an incremental improvement of 7.3 months, while the doublet showed a 5.4-month improvement over fulvestrant. These findings highlight the potential of gedatolisib to set new efficacy benchmarks for treating advanced breast cancer.

Dr. Sara Hurvitz, a co-principal investigator for the trial, emphasized the significance of these findings, stating, “To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control.”

Additionally, the overall safety profile of both gedatolisib combinations proved to be better than those seen in earlier trials. Treatment discontinuation rates due to adverse events were lower compared to other approved therapies, suggesting a better tolerance among patients.

The company plans to submit a New Drug Application (NDA) for gedatolisib to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. Full results from the VIKTORIA-1 trial are expected to be presented at a medical conference later this year.

Brian Sullivan, CEO of Celcuity, expressed excitement about the potential impact of these findings, stating, “The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population.”