Celcuity Inc. (NASDAQ:CELC) stock surged on Monday after the company reported topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, which evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant.
The trial included adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant.
The median (mPFS) was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant.
The mPFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.
The company said on Monday that the topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer:
- The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.
- The 7.3- and 5.4-month incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy.
Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year.
Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025.
Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.
The company is also conducting the VIKTORIA-2 Phase 3 trial to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor compared to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy-resistant.
The company dosed the first patient in the VIKTORIA-2 trial in July.
In July, Celcuity secured a U.S. Patent covering the clinical dosing regimen for its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients. The patent extends Celcuity’s patent exclusivity in the U.S. into 2042.
In June, Celcuity released preliminary clinical data for gedatolisib in two early-phase clinical trials.
In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer, the six-month radiographic progression-free survival rate was 66%.
In a Phase 2 trial of gedatolisib plus trastuzumab-pkrb as third line+ therapy in patients with HER2+ metastatic breast cancer, the objective response rate was 43%.
Price Action: CELC stock is trading higher by 222.2% to $44.37 premarket at last check Monday.
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