Celcuity's Gedatolisib Shows Superior Efficacy in Phase 3 Breast Cancer Trial

summarizeSummary

Celcuity announced detailed positive Phase 3 trial results for gedatolisib in PIK3CA mutant breast cancer, showing superior efficacy and a favorable safety profile, reinforcing its potential as a new standard of care.

check_boxKey Events

• Superior Efficacy in PIK3CA Mutant Breast Cancer

  The gedatolisib-triplet regimen doubled the likelihood of survival without disease progression or death (HR=0.50; p<0.0001) and achieved a median progression-free survival (PFS) of 11.1 months versus 5.6 months for the comparator (alpelisib plus fulvestrant).

• New Milestones Achieved

  The VIKTORIA-1 trial is the first Phase 3 study to demonstrate superiority of one PAM inhibitor over another. The gedatolisib-triplet also achieved the highest reported median PFS (11.1 months) and objective response rate (48.9%) in second-line HR+/HER2- advanced breast cancer.

• Favorable Safety Profile

  Both gedatolisib regimens were generally well tolerated with mostly low-grade treatment-related adverse events and lower discontinuation rates compared to the alpelisib plus fulvestrant group.

• Upcoming sNDA Submission

  Celcuity intends to submit these detailed data as a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

auto_awesomeAnalysis

This filing provides detailed, highly positive efficacy and safety results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial for gedatolisib. The data demonstrates statistically significant and clinically meaningful superiority over a comparator drug, establishing new benchmarks for progression-free survival and objective response rates in this patient population. These results strengthen the drug's commercial potential and will support a supplemental New Drug Application (sNDA) submission, building on the existing FDA Priority Review for the wild-type cohort.