Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial

Core Insights - Celcuity Inc. has announced that the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled and expects to report topline data in late Q1 or Q2 2026 [2] - The company provided updated analysis from a Phase 1b clinical trial evaluating gedatolisib combined with fulvestrant and palbociclib in patients with HR+/HER2- advanced breast cancer [2][6] Company Updates - The VIKTORIA-1 study is evaluating gedatolisib plus fulvestrant with and without palbociclib against alpelisib and fulvestrant in patients with hormone receptor-positive, HER2-negative, PIK3CA mutant tumors [1] - The Phase 1b trial included patients treated with the same drug regimen as in the VIKTORIA-1 study, with a focus on efficacy data [2][4] Clinical Trial Data - In the Phase 1b trial, patients with PIK3CA mutant tumors had a median progression-free survival (PFS) of 14.6 months and an objective response rate (ORR) of 48% [4][6] - For patients receiving the intermittent dose of gedatolisib, median PFS was 19.7 months and ORR was 64% for those with PIK3CA mutant tumors [4][5] - In contrast, patients with PIK3CA wild-type tumors had a median PFS of 9.0 months and an ORR of 41% [4][5] Future Outlook - The company is optimistic about the results from the PIK3CA mutant patient subgroup and looks forward to reporting Phase 3 data in 2026 [6][7] - Celcuity is also conducting other clinical trials, including VIKTORIA-2, which is currently enrolling patients [7]