Following the announcement of noteworthy clinical trial advancements, Celcuity Inc. (NASDAQ: CELC) stock saw a surge in value. The CELC stock was trading at $38.31 as of the most recent check, representing a remarkable 178.18% increase. The company’s Phase 3 VIKTORIA-1 trial’s PIK3CA wild-type group showed encouraging topline findings.
After advancement on a CDK4/6 inhibitor and an aromatase inhibitor, the research compared gedatolisib with fulvestrant—with or without palbociclib—against fulvestrant in patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA wild-type, locally advanced, or metastatic breast cancer.
Revolutionary Progression-Free Survival Results
In comparison to fulvestrant, the gedatolisib triplet showed a 76% decrease in the probability of disease progression or death, resulting in a statistically significant and clinically relevant increase in progression-free survival (PFS) (HR 0.24, 95% CI).
According to the blinded independent central review (BICR), the median PFS was 9.3 months as opposed to 2.0 months with fulvestrant, representing a 7.3-month incremental improvement. With a 67% risk reduction and a 5.4-month advantage in mPFS from 2.0 months to 7.4 months, the gedatolisib doublet demonstrated comparable remarkable outcomes.
Significant Advances in the Treatment of Advanced Breast Cancer
For patients with HR+/HER2-advanced breast cancer receiving at least a second-line treatment, these results represent the highest favorable hazard ratios and PFS improvements yet documented in Phase 3 studies.
Following CDK4/6 inhibitor advancement, gedatolisib becomes the first PI3K/AKT/mTOR pathway inhibitor to provide favorable Phase 3 results in HR+/HER2-/PIK3CA wild-type patients. Notably, both gedatolisib regimens showed better tolerability, fewer cases of stomatitis and hyperglycemia, and lower treatment dropout rates than observed in previous studies.
Regulatory Route and Prospects
The findings offer gedatolisib as a potentially revolutionary alternative for patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer. In Q4 2025, Celcuity intends to file a New Drug Application with the US Food and Drug Administration.
By the end of 2025, topline findings for the VIKTORIA-1 PIK3CA mutation cohort are also expected. The trial’s significant PFS improvement points to a paradigm shift in the treatment strategy for this difficult patient group.
