Celcuity Inc. has initiated VIKTORIA-2, a Phase 3 clinical trial investigating gedatolisib combined with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for endocrine therapy-resistant HR+/HER2- advanced breast cancer. This trial builds upon promising Phase 1b results where gedatolisib, in combination with palbociclib and letrozole, demonstrated substantial median progression-free survival (48.6 months), overall survival (77.3 months), and objective response rate (79%) in endocrine-sensitive patients. The trial aims to address the unmet need for more effective therapies in patients who experience disease progression on or within 12 months of completing adjuvant endocrine treatment.
This advancement is critical because current standard-of-care treatments offer limited benefit to this patient population. The encouraging results from the earlier-phase trial suggest that comprehensive PAM pathway inhibition with gedatolisib could significantly improve outcomes for these patients, potentially changing the treatment landscape for advanced breast cancer. The focus on endocrine therapy-resistant patients specifically addresses a critical gap in current therapeutic options.
VIKTORIA-2 is a randomized, open-label trial comparing gedatolisib in combination with fulvestrant and a CDK4/6 inhibitor (either ribociclib or palbociclib) to fulvestrant plus a CDK4/6 inhibitor alone. The trial will enroll approximately 638 patients, stratified by PIK3CA mutation status, across approximately 200 sites globally. The primary endpoint is progression-free survival, assessed independently for PIK3CA wild-type and mutant subjects. A safety run-in will assess the combination of gedatolisib, ribociclib, and fulvestrant.
The initiation of VIKTORIA-2 marks a significant step for Celcuity and the development of gedatolisib. Positive results from this trial could lead to a new first-line treatment option for patients with advanced breast cancer who have limited effective therapies, potentially positioning gedatolisib as a key player in the oncology market. The trial’s global scope and focus on PIK3CA status will also provide valuable data on the efficacy and safety of gedatolisib across a diverse patient population. This information is crucial for tailoring future treatment strategies and further developing personalized cancer therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
