Celcuity Inc. (NASDAQ:CELC) saw its stock soar by more than 100% on Monday following the release of groundbreaking Phase 3 trial data for its experimental breast cancer drug, gedatolisib. The therapy demonstrated unprecedented effectiveness in patients with hormone receptor-positive, HER2-negative advanced breast cancer.
According to the company, the combination of gedatolisib with palbociclib and fulvestrant—known as the triplet regimen—lowered the risk of disease progression or death by 76% compared to treatment with fulvestrant alone in patients without the PIK3CA gene mutation. A doublet regimen, consisting of gedatolisib and fulvestrant, also showed impressive results, reducing the risk by 67%.
These outcomes mark a significant achievement in breast cancer research, with hazard ratios surpassing those of any prior Phase 3 studies involving this subtype of the disease. The triplet therapy extended median progression-free survival by 7.3 months, while the doublet delivered a 5.4-month improvement versus fulvestrant monotherapy.
“The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. 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,”
— said Dr. Sara Hurvitz, co-principal investigator of the trial and Senior Vice President at Fred Hutchinson Cancer Center.
Safety results were also encouraging. Celcuity reported lower discontinuation rates due to adverse effects compared to prior studies or existing approved combination therapies, suggesting a more tolerable treatment option for patients.
The company intends to submit a New Drug Application to the U.S. FDA in the fourth quarter of 2025. A full presentation of data from the PIK3CA wild-type group is planned for an upcoming medical meeting, while topline results for the PIK3CA mutation cohort are expected by year-end.
Gedatolisib is classified as a multi-target PAM inhibitor, uniquely designed to block all four class I PI3K isoforms as well as mTOR complexes—a feature that distinguishes it from existing single-target cancer drugs and may underlie its strong performance.
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