Celcuity’s stock has soared by more than 200% after its combination therapy improved progression-free survival (PFS) in HR+/HER2- advanced breast cancer patients by more than seven months.
The Phase III VIKTORIA-1 trial (NCT05501886) is evaluating a triple combination of gedatolisib, Ibrance (palbociclib) and Faslodex (fulvestrant), a double combination of gedatolisib and Faslodex compared to Faslodex alone.
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The triple combination reduced the risk of disease progression or death by 76%, while the double combination therapy reduced the risk of progression or death by 67% compared to Faslodex alone.
Median PFS was 9.3 months with the gedatolisib triple therapy and 7.4 months with the double therapy compared to 2.0 months with Faslodex alone.
The trial enrolled 701 patients with HR-positive, HER2-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, whose disease progressed on or after treatment with a CDK4/6 inhibitor.
“The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing,” said senior vice president of the clinical research division at Fred Hutchinson Cancer Center, Dr. Sara Hurvitz. “To my knowledge, we have not seen Phase III 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.”
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By GlobalDataThe safety profile with both combinations was better than seen in the Phase Ib trial and lower than observed in any Phase III trials for currently approved drug combinations in HR+/HER2- advanced breast cancer.
Celcuity’s stock surged 233.76%, opening at $45.96 on 28 July, up from a closing price of $13.77 market on 25 July.
Based on the successful trial data, Celcuity plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in Q4 2025.
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, while topline data for the PIK3CA mutation cohort is expected by the end of 2025.
Second-line therapy promise
CDK4/6 inhibitors in combination with endocrine therapy are the recommended first-line treatment for HR+, HER2-negative advanced or metastatic breast cancer. Approximately 20% of those patients are resistant to CDK4/6 inhibitors, while other patients will eventually develop acquired resistance after a period of response.
Therefore, a meaningful improvement in second-line therapies such as gedatolisib is notable.
Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway. The therapy is also being investigated in the Phase III VIKTORIA-2 trial (NCT06757634).
According to the World Health Organization (WHO), breast cancer was the most diagnosed cancer in women in 157 out of 185 countries in 2022 and is the leading cause of cancer death in women globally.
GlobalData epidemiologists forecast that diagnosed incident cases of invasive HER2- breast cancer will increase from 809,781 cases in 2024 to 904,992 cases in 2034 across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and urban China).
GlobalData is the parent company of Clinical Trials Arena.
