Celcuity Phase 3 VIKTORIA-1 Trial Meets Primary Endpoint in PIK3CA Mutant Breast Cancer Cohort

On May 1, 2026, Celcuity Inc. announced positive topline results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial. The trial evaluated gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, in combination with fulvestrant (with or without palbociclib) for patients with HR+/HER2- advanced breast cancer following progression on CDK4/6 inhibitor therapy. The primary efficacy analysis showed that the gedatolisib triplet (gedatolisib, fulvestrant, and palbociclib) achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the standard-of-care combination of alpelisib and fulvestrant. Additionally, a secondary endpoint comparing the gedatolisib doublet to alpelisib plus fulvestrant also demonstrated significant PFS improvement. Both gedatolisib regimens were well tolerated with no new safety signals. Based on these results, Celcuity plans to submit a supplemental New Drug Application (sNDA) to the FDA. Detailed data will be presented at the ASCO Annual Meeting in June 2026. Separately, the FDA has assigned a PDUFA date of July 17, 2026, for the company's initial NDA for gedatolisib in the PIK3CA wild-type population.